Tirzepatide History and Updates

250 events · 2016 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

24
FDA Approvals
0
Label Revisions
652
Trial Milestones
10
Pivotal Publications
Tirzepatide — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20162017201820192020202120222023202420252026202720282029203020312032Trial: NCT06180616 2026-12-31 → 2028-12-31 (primary completion)Trial: NCT07468552 2026-11-15 → 2028-03-15 (primary completion)Trial: NCT07078838 2026-08-31 → 2029-03-31 (primary completion)Trial: NCT07298915 2026-08-31 → 2026-12-31 (primary completion)Trial: NCT06732245 2026-08-15 → 2027-08-15 (primary completion)Trial: NCT07630454 2026-08-01 → 2029-08-01 (primary completion)Trial: NCT07573163 2026-07-31 → 2028-07-31 (primary completion)Trial: NCT07349641 2026-07-06 → 2028-12-31 (primary completion)Trial: NCT06820281 2026-07-01 → 2027-12-31 (primary completion)Trial: NCT07265752 2026-07-01 → 2028-06-30 (primary completion)Trial: NCT07554638 2026-06-30 → 2029-04-30 (primary completion)Trial: NCT07605247 2026-06-01 → 2028-01-31 (primary completion)Trial: NCT07567378 2026-05-31 → 2027-11-30 (primary completion)Trial: NCT07602699 2026-05-31 → 2028-03-31 (primary completion)Trial: NCT07559500 2026-05-24 → 2031-12-31 (primary completion)Trial: NCT07179120 2026-05-01 → 2026-08-12 (primary completion)Trial: NCT07382024 2026-05-01 → 2027-12-31 (primary completion)Trial: NCT07218445 2026-04-30 → 2027-09-18 (primary completion)Trial: NCT07555730 2026-04-30 → 2028-09-30 (primary completion)Trial: NCT07065552 2026-04-27 → 2028-07-31 (primary completion)Trial: NCT07228741 2026-04-23 → 2027-11-30 (primary completion)Trial: NCT07527910 2026-04-20 → 2029-11-27 (primary completion)Trial: NCT07257484 2026-04-06 → 2027-10-06 (primary completion)Trial: NCT07504172 2026-04-01 → 2026-07-01 (primary completion)Trial: NCT07046819 2026-04-01 → 2026-07-30 (primary completion)Trial: NCT06811324 2026-04-01 → 2027-04-01 (primary completion)Trial: NCT07483801 2026-03-31 → 2027-04-30 (primary completion)Trial: NCT07492563 2026-03-31 → 2026-10-31 (primary completion)Trial: NCT07521631 2026-03-31 → 2027-02-04 (primary completion)Trial: NCT07443956 2026-03-09 → 2028-02-29 (primary completion)Trial: NCT07463846 2026-03-02 → 2028-02-01 (primary completion)Trial: NCT07191873 2026-02-28 → 2027-02-28 (primary completion)Trial: NCT07438444 2026-02-27 → 2027-10-31 (primary completion)Trial: NCT07220473 2026-02-27 → 2027-11-30 (primary completion)Trial: NCT07095517 2026-02-24 → 2027-03-31 (primary completion)Trial: NCT07481747 2026-02-02 → 2027-02-14 (primary completion)Trial: NCT07176663 2026-02-01 → 2026-04-01 (primary completion)Trial: NCT07373834 2026-01-31 → 2026-12-31 (primary completion)Trial: NCT07364175 2026-01-31 → 2027-01-31 (primary completion)Trial: NCT06651177 2026-01-29 → 2027-09-30 (primary completion)Trial: NCT07417618 2026-01-27 → 2026-05-22 (primary completion)Trial: NCT07202247 2026-01-23 → 2028-04-09 (primary completion)Trial: NCT07292519 2026-01-15 → 2027-05-15 (primary completion)Trial: NCT07299084 2026-01-14 → 2026-11-30 (primary completion)Trial: NCT07284511 2026-01-05 → 2028-01-31 (primary completion)Trial: NCT07423247 2026-01-01 → 2026-07-31 (primary completion)Trial: NCT07319975 2025-12-29 → 2026-10-31 (primary completion)Trial: NCT07326111 2025-12-09 → 2028-12-31 (primary completion)Trial: NCT07247084 2025-11-24 → 2029-07-31 (primary completion)Trial: NCT06935838 2025-11-12 → 2026-07-31 (primary completion)Trial: NCT05933499 2025-11-05 → 2028-12-31 (primary completion)Trial: NCT07245771 2025-11-04 → 2027-02-15 (primary completion)Trial: NCT07128082 2025-10-30 → 2026-12-31 (primary completion)Trial: NCT07165028 2025-10-15 → 2030-08-31 (primary completion)Trial: NCT07154719 2025-10-09 → 2027-02-01 (primary completion)Trial: NCT06994338 2025-10-06 → 2026-08-31 (primary completion)Trial: NCT06801015 2025-10-01 → 2028-01-31 (primary completion)Trial: NCT07099742 2025-09-30 → 2026-04-30 (primary completion)Trial: NCT07203677 2025-09-19 → 2025-10-15 (primary completion)Trial: NCT06847399 2025-09-17 → 2027-12-01 (primary completion)Trial: NCT06727331 2025-09-15 → 2026-05-31 (primary completion)Trial: NCT07091734 2025-09-08 → 2029-09-30 (primary completion)Trial: NCT06073184 2025-08-31 → 2027-02-28 (primary completion)Trial: NCT07096908 2025-07-31 → 2028-02-25 (primary completion)Trial: NCT06861439 2025-07-07 → 2026-09-30 (primary completion)Trial: NCT06759701 2025-07-02 → 2026-12-31 (primary completion)Trial: NCT06934642 2025-06-30 → 2026-08-31 (primary completion)Trial: NCT06937099 2025-06-26 → 2028-05-31 (primary completion)Trial: NCT06937086 2025-06-26 → 2028-04-30 (primary completion)Trial: NCT07000955 2025-06-17 → 2026-09-30 (primary completion)Trial: NCT07293325 2025-06-02 → 2027-04-02 (primary completion)Trial: NCT06901349 2025-05-23 → 2025-06-10 (primary completion)Trial: NCT06976853 2025-05-13 → 2028-05-31 (primary completion)Trial: NCT06962280 2025-05-12 → 2026-11-30 (primary completion)Trial: NCT06939088 2025-05-05 → 2028-08-01 (primary completion)Trial: NCT06965413 2025-05-05 → 2026-08-24 (primary completion)Trial: NCT06901245 2025-05-01 → 2026-06-30 (primary completion)Trial: NCT07057310 2025-05-01 → 2026-12-31 (primary completion)Trial: NCT06914895 2025-04-25 → 2026-11-30 (primary completion)Trial: NCT06916065 2025-04-09 → 2026-01-19 (primary completion)Trial: NCT06802081 2025-04-08 → 2026-12-31 (primary completion)Trial: NCT06911203 2025-04-03 → 2026-01-11 (primary completion)Trial: NCT06721507 2025-03-27 → 2026-12-31 (primary completion)Trial: NCT06890611 2025-03-25 → 2025-09-26 (primary completion)Trial: NCT06857942 2025-03-19 → 2028-05-31 (primary completion)Trial: NCT06893211 2025-03-18 → 2025-11-30 (primary completion)Trial: NCT06734273 2025-03-10 → 2027-09-30 (primary completion)Trial: NCT06864026 2025-03-06 → 2027-11-30 (primary completion)Trial: NCT06582875 2025-03-06 → 2029-06-30 (primary completion)Trial: NCT06774079 2025-03-05 → 2027-03-05 (primary completion)Trial: NCT06630585 2025-02-14 → 2026-06-30 (primary completion)Trial: NCT06737042 2025-02-12 → 2026-02-09 (primary completion)Trial: NCT06745128 2025-02-03 → 2026-03-31 (primary completion)Trial: NCT06803888 2025-01-29 → 2027-07-01 (primary completion)Trial: NCT06914141 2025-01-14 → 2025-06-01 (primary completion)Trial: NCT06914154 2025-01-14 → 2025-06-01 (primary completion)Trial: NCT06657209 2025-01-13 → 2027-12-15 (primary completion)Trial: NCT06980623 2025-01-01 → 2025-11-30 (primary completion)Trial: NCT06918405 2025-01-01 → 2026-06-30 (primary completion)Trial: NCT06751589 2024-12-19 → 2027-12-31 (primary completion)Trial: NCT07303556 2024-12-18 → 2025-07-01 (primary completion)Trial: NCT06700538 2024-12-04 → 2027-09-17 (primary completion)Trial: NCT06648031 2024-12-04 → 2025-07-31 (primary completion)Trial: NCT06517212 2024-11-26 → 2029-08-31 (primary completion)Trial: NCT06191848 2024-11-19 → 2027-05-31 (primary completion)Trial: NCT06246799 2024-11-07 → 2029-04-30 (primary completion)Trial: NCT06534411 2024-11-05 → 2026-06-02 (primary completion)Trial: NCT06779929 2024-11-01 → 2025-12-01 (primary completion)Trial: NCT06662383 2024-11-01 → 2026-12-31 (primary completion)Trial: NCT06162715 2024-10-30 → 2027-05-31 (primary completion)Trial: NCT06518837 2024-10-30 → 2027-09-30 (primary completion)Trial: NCT06643728 2024-10-21 → 2026-04-30 (primary completion)Trial: NCT06635057 2024-10-11 → 2026-04-30 (primary completion)Trial: NCT07088718 2024-10-01 → 2025-07-30 (primary completion)Trial: NCT07096063 2024-10-01 → 2025-07-15 (primary completion)Trial: NCT06606821 2024-10-01 → 2027-03-20 (primary completion)Trial: NCT06588283 2024-09-30 → 2026-01-08 (primary completion)Trial: NCT06588296 2024-09-24 → 2025-11-18 (primary completion)Trial: NCT06603571 2024-09-20 → 2026-06-30 (primary completion)Trial: NCT06485089 2024-09-14 → 2026-03-25 (primary completion)Trial: NCT06565611 2024-08-05 → 2025-02-05 (primary completion)Trial: NCT06515418 2024-06-27 → 2025-02-06 (primary completion)Trial: NCT06439277 2024-06-03 → 2027-10-31 (primary completion)Trial: NCT06445075 2024-05-21 → 2025-03-04 (primary completion)Trial: NCT06373146 2024-04-24 → 2025-12-15 (primary completion)Trial: NCT06297616 2024-04-15 → 2025-11-21 (primary completion)Trial: NCT06345066 2024-04-03 → 2025-09-29 (primary completion)Trial: NCT06326060 2024-03-18 → 2025-04-10 (primary completion)Trial: NCT06301256 2024-03-11 → 2025-03-11 (primary completion)Trial: NCT06221969 2024-01-16 → 2026-03-04 (primary completion)Trial: NCT05708859 2024-01-02 → 2025-12-31 (primary completion)Trial: NCT05659368 2024-01-01 → 2024-10-31 (primary completion)Trial: NCT06131437 2023-11-27 → 2025-12-08 (primary completion)Trial: NCT06143956 2023-11-17 → 2027-09-30 (primary completion)Trial: NCT05912621 2023-11-09 → 2028-06-30 (primary completion)Trial: NCT06075667 2023-10-16 → 2026-05-31 (primary completion)Trial: NCT06037252 2023-09-21 → 2026-01-08 (primary completion)Trial: NCT06047548 2023-09-20 → 2026-01-20 (primary completion)Trial: NCT07309094 2023-09-15 → 2027-07-31 (primary completion)Trial: NCT06009653 2023-09-13 → 2024-05-29 (primary completion)Trial: NCT05963022 2023-08-21 → 2024-10-09 (primary completion)Trial: NCT05990374 2023-08-01 → 2024-01-01 (primary completion)Trial: NCT05978713 2023-07-31 → 2024-03-12 (primary completion)Trial: NCT06354101 2023-07-01 → 2023-07-01 (primary completion)Trial: NCT05756764 2023-06-01 → 2026-01-30 (primary completion)Trial: NCT05822544 2023-04-22 → 2026-02-28 (primary completion)Trial: NCT05822830 2023-04-21 → 2024-11-13 (primary completion)Trial: NCT05810597 2023-04-03 → 2023-07-17 (primary completion)Trial: NCT05706506 2023-03-08 → 2023-10-31 (primary completion)Trial: NCT05536804 2023-02-08 → 2026-09-30 (primary completion)Trial: NCT05696847 2023-02-07 → 2025-01-16 (primary completion)Trial: NCT05691712 2023-02-05 → 2024-07-01 (primary completion)Trial: NCT05564039 2022-11-30 → 2024-07-15 (primary completion)Trial: NCT05582096 2022-11-11 → 2023-06-08 (primary completion)Trial: NCT05556512 2022-10-11 → 2027-10-31 (primary completion)Trial: NCT05766358 2022-10-06 → 2024-05-24 (primary completion)Trial: NCT05433584 2022-08-01 → 2025-10-21 (primary completion)Trial: NCT05412004 2022-06-21 → 2024-03-12 (primary completion)Trial: NCT05260021 2022-04-13 → 2024-07-30 (primary completion)Trial: NCT05553093 2022-03-15 → 2023-12-31 (primary completion)Trial: NCT05024032 2021-09-01 → 2022-12-27 (primary completion)Trial: NCT04844918 2021-05-10 → 2023-06-24 (primary completion)Trial: NCT04847557 2021-04-20 → 2024-07-02 (primary completion)Trial: NCT04657016 2021-03-29 → 2023-04-20 (primary completion)Trial: NCT04657003 2021-03-29 → 2023-03-16 (primary completion)Trial: NCT04660643 2021-03-29 → 2023-04-25 (primary completion)Trial: NCT04235959 2020-10-21 → 2021-08-17 (primary completion)Trial: NCT04537923 2020-10-19 → 2022-10-11 (primary completion)Trial: NCT04407234 2020-09-15 → 2021-01-07 (primary completion)Trial: NCT04311411 2020-08-24 → 2022-12-16 (primary completion)Trial: NCT04311424 2020-07-28 → 2020-10-02 (primary completion)Trial: NCT04081337 2020-07-09 → 2022-05-26 (primary completion)Trial: NCT04255433 2020-05-29 → 2025-06-12 (primary completion)Trial: NCT04172987 2020-02-26 → 2021-02-09 (primary completion)Trial: NCT04050553 2020-02-24 → 2022-01-25 (primary completion)Trial: NCT04093752 2019-12-09 → 2021-11-01 (primary completion)Trial: NCT04184622 2019-12-04 → 2022-04-01 (primary completion)Trial: NCT04166773 2019-11-19 → 2023-12-11 (primary completion)Trial: NCT04050670 2019-09-13 → 2020-04-03 (primary completion)Trial: NCT04039503 2019-08-30 → 2020-12-22 (primary completion)Trial: NCT04004988 2019-08-19 → 2019-12-16 (primary completion)Trial: NCT03987919 2019-07-30 → 2021-01-28 (primary completion)Trial: NCT03940742 2019-07-22 → 2020-09-22 (primary completion)Trial: NCT03951753 2019-06-28 → 2021-04-08 (primary completion)Trial: NCT03954834 2019-06-03 → 2020-10-05 (primary completion)Trial: NCT03861052 2019-05-07 → 2021-03-10 (primary completion)Trial: NCT03882970 2019-04-01 → 2020-12-11 (primary completion)Trial: NCT03861039 2019-03-30 → 2021-01-26 (primary completion)Trial: NCT03730662 2018-11-20 → 2021-01-22 (primary completion)Trial: NCT03482024 2018-03-30 → 2019-08-19 (primary completion)Trial: NCT03375463 2017-12-19 → 2018-12-27 (primary completion)Trial: NCT03322631 2017-11-15 → 2018-05-29 (primary completion)Trial: NCT03311724 2017-10-19 → 2018-04-24 (primary completion)Trial: NCT03131687 2017-05-24 → 2018-08-01 (primary completion)Trial: NCT02759107 2016-05-11 → 2017-06-26 (primary completion)FDA approval — 2022-05-13 FDA approved Mounjaro (tirzepatide) (NDA 215866) Sponsor: ELI LILLY AND CO. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2023-07-28 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-6) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2023-07-28 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-2) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval — 2023-11-08 FDA approved Zepbound (tirzepatide) (NDA 217806) Sponsor: ELI LILLY AND CO. Class: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated.FDA approval (supplemental) — 2024-03-28 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-3) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-10-18 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-5) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-10-18 FDA approved supplemental application for Zepbound (tirzepatide) — Efficacy (NDA 217806 S-6) Sponsor: ELI LILLY AND CO. Class: Efficacy.FDA approval (supplemental) — 2024-10-18 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-19) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-10-18 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-15) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-10-18 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-11) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-11-01 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-10) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-11-01 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-15) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-11-01 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-22) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2024-12-20 FDA approved supplemental application for Zepbound (tirzepatide) — Efficacy (NDA 217806 S-13) Sponsor: ELI LILLY AND CO. Class: Efficacy.FDA approval (supplemental) — 2025-02-07 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-20) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2025-05-28 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-31) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2025-09-25 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-31) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2025-09-25 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-34) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2025-12-19 FDA approved supplemental application for Mounjaro (tirzepatide) — Efficacy (NDA 215866 S-39) Sponsor: ELI LILLY AND CO. Class: Efficacy.FDA approval (supplemental) — 2026-01-07 FDA approved supplemental application for Zepbound (tirzepatide) — Manufacturing (CMC) (NDA 217806 S-37) Sponsor: ELI LILLY AND CO. Class: Manufacturing (CMC).FDA approval (supplemental) — 2026-01-07 FDA approved supplemental application for Mounjaro (tirzepatide) — Manufacturing (CMC) (NDA 215866 S-41) Sponsor: ELI LILLY AND CO. Class: Manufacturing (CMC).FDA approval (supplemental) — 2026-01-20 FDA approved supplemental application for Mounjaro (tirzepatide) — Labeling (NDA 215866 S-9) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2026-01-20 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-2) Sponsor: ELI LILLY AND CO. Class: Labeling.FDA approval (supplemental) — 2026-02-25 FDA approved supplemental application for Zepbound (tirzepatide) — Labeling (NDA 217806 S-42) Sponsor: ELI LILLY AND CO. Class: Labeling.Results posted — 2019-08-20 Trial results posted: NCT03131687 A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes MellitusResults posted — 2021-05-19 Trial results posted: NCT03311724 A Study of Tirzepatide (LY3298176) in Participants With Type 2 DiabetesResults posted — 2021-10-20 Trial results posted: NCT03954834 A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise AloneResults posted — 2022-01-12 Trial results posted: NCT04039503 A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or WResults posted — 2022-01-19 Trial results posted: NCT03882970 A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 DiabetesResults posted — 2022-02-14 Trial results posted: NCT03987919 A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 DiabetesResults posted — 2022-02-14 Trial results posted: NCT03861039 A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 DiabetesResults posted — 2022-02-14 Trial results posted: NCT03730662 A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased CardiovResults posted — 2022-04-14 Trial results posted: NCT03861052 A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 DiabetesResults posted — 2023-01-06 Trial results posted: NCT04093752 A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)Results posted — 2023-03-20 Trial results posted: NCT03951753 A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)Results posted — 2023-03-23 Trial results posted: NCT03322631 A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 DiabetesResults posted — 2023-03-23 Trial results posted: NCT03482024 A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney FunctionResults posted — 2023-03-24 Trial results posted: NCT03940742 A Study of Tirzepatide in Participants With Impaired Liver FunctionResults posted — 2023-03-24 Trial results posted: NCT04050670 A Study of Tirzepatide at Different Injection Sites in Participants With Different Body SizesResults posted — 2023-03-24 Trial results posted: NCT04311424 Study of Tirzepatide in Healthy ParticipantsResults posted — 2023-03-27 Trial results posted: NCT04172987 A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female ParticipantsResults posted — 2023-04-18 Trial results posted: NCT04004988 A Study of Tirzepatide Administered by Two Different Devices in Healthy ParticipantsResults posted — 2023-04-24 Trial results posted: NCT04184622 A Study of Tirzepatide (LY3298176) in Participants With Obesity or OverweightResults posted — 2023-07-06 Trial results posted: NCT04235959 A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes MellitusResults posted — 2023-11-02 Trial results posted: NCT04537923 A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin GlarResults posted — 2024-01-08 Trial results posted: NCT04407234 A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using TirzepatideResults posted — 2024-01-16 Trial results posted: NCT02759107 A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)Results posted — 2024-01-19 Trial results posted: NCT05024032 A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)Results posted — 2024-02-05 Trial results posted: NCT03375463 A Study of Tirzepatide (LY3298176) in Healthy ParticipantsResults posted — 2024-02-08 Trial results posted: NCT04081337 A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using TirzepatideResults posted — 2024-04-08 Trial results posted: NCT04657003 A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are OverweightResults posted — 2024-05-16 Trial results posted: NCT04657016 A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss ProgramResults posted — 2024-05-20 Trial results posted: NCT04050553 A Study of Tirzepatide in Participants With Type 2 Diabetes MellitusResults posted — 2024-05-22 Trial results posted: NCT04660643 A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight LossResults posted — 2024-05-22 Trial results posted: NCT04311411 A Study of Tirzepatide in Overweight and Very Overweight ParticipantsResults posted — 2024-07-16 Trial results posted: NCT04844918 A Study of Tirzepatide (LY3298176) in Participants With Obesity DiseaseResults posted — 2024-10-15 Trial results posted: NCT05810597 A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection DevicesResults posted — 2024-12-13 Trial results posted: NCT05706506 A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)Results posted — 2025-01-24 Trial results posted: NCT04166773 A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)Results posted — 2025-04-27 Trial results posted: NCT05978713 A Study of Tirzepatide (LY3298176) in Healthy Lactating FemalesResults posted — 2025-04-30 Trial results posted: NCT05412004 Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep ApneaResults posted — 2025-08-03 Trial results posted: NCT05564039 A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)Results posted — 2025-08-08 Trial results posted: NCT05691712 A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 DiabetesResults posted — 2025-08-20 Trial results posted: NCT04847557 A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT TrialResults posted — 2025-08-26 Trial results posted: NCT05696847 A Study of Tirzepatide (LY3298176) in Pediatric Participants With ObesityResults posted — 2025-09-26 Trial results posted: NCT05260021 A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled WResults posted — 2025-10-21 Trial results posted: NCT05963022 A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)Results posted — 2025-11-26 Trial results posted: NCT05822830 A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related ComorbiditiesPivotal publication — 2023-01-01 Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. (JAMA) SURPASS-6 — A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without MetforminPivotal publication — 2023-01-01 Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, p (Lancet) SURMOUNT-2 — A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are OverweightPivotal publication — 2024-01-01 Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. (N Engl J Med) SURMOUNT-OSA — Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep ApneaPivotal publication — 2024-01-01 Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. (JAMA) SURMOUNT-CN — A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)Pivotal publication — 2024-01-01 Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. (JAMA) SURMOUNT-4 — A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight LossPivotal publication — 2025-01-01 Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. (N Engl J Med) A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT TrialPivotal publication — 2025-01-01 Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. (N Engl J Med) SURMOUNT-5 — A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related ComorbiditiesPivotal publication — 2025-01-01 Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 tria (Lancet) SURPASS-PEDS — A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or BothPivotal publication — 2025-01-01 Tirzepatide for Obesity Treatment and Diabetes Prevention. (N Engl J Med) SURMOUNT-1 — A Study of Tirzepatide (LY3298176) in Participants With Obesity or OverweightPivotal publication — 2025-01-01 Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. (N Engl J Med) SURPASS-CVOT — A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetestoday (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Tirzepatide since 2016, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (19)

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obe
Primary completion· ClinicalTrials.gov
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Primary completion· ClinicalTrials.gov
Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity
Trial started· ClinicalTrials.gov
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometr
Trial started· ClinicalTrials.gov
Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF
Primary completion· ClinicalTrials.gov
Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health
Primary completion· ClinicalTrials.gov
A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepati
Trial started· ClinicalTrials.gov
Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer
Primary completion· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
Primary completion· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participant
Primary completion· ClinicalTrials.gov
Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women
Primary completion· ClinicalTrials.gov
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Primary completion· ClinicalTrials.gov
A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-rela
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbi
Primary completion· ClinicalTrials.gov
Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy
Primary completion· ClinicalTrials.gov
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

Past events

2026
Primary completion· ClinicalTrials.gov
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated
Primary completion· ClinicalTrials.gov
Tirzepatide vs Semaglutide in Individuals at Cardiovascular Risk But Without Diabetes.
Primary completion· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Trial started· ClinicalTrials.gov
CARTIZ Registry: Cartilage, Arthropathy and Imaging Under Tirzepatide in Zone-stratified Cohorts - A Four-Institute Mexican Observational Re
Primary completion· ClinicalTrials.gov
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
Trial started· ClinicalTrials.gov
Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health
Trial started· ClinicalTrials.gov
Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
Trial started· ClinicalTrials.gov
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Trial started· ClinicalTrials.gov
AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)
Primary completion· ClinicalTrials.gov
Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
Primary completion· ClinicalTrials.gov
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Ob
Trial started· ClinicalTrials.gov
Tirzepatide in Women With Obesity and Endometrial Intra-epithelial Neoplasia or Grade 1 Endometrial Cancer
Trial started· ClinicalTrials.gov
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
Trial started· ClinicalTrials.gov
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
Trial started· ClinicalTrials.gov
Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity
Primary completion· ClinicalTrials.gov
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
Trial started· ClinicalTrials.gov
Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
Trial started· ClinicalTrials.gov
Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated
Trial started· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
Primary completion· ClinicalTrials.gov
Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants
Trial started· ClinicalTrials.gov
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbi
Trial started· ClinicalTrials.gov
Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure
Trial started· ClinicalTrials.gov
A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-rela
Trial started· ClinicalTrials.gov
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Trial started· ClinicalTrials.gov
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
Trial started· ClinicalTrials.gov
Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostat
Primary completion· ClinicalTrials.gov
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-R
Primary completion· ClinicalTrials.gov
A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity
Primary completion· ClinicalTrials.gov
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Ob
Trial started· ClinicalTrials.gov
Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)
Trial started· ClinicalTrials.gov
A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participant
Primary completion· ClinicalTrials.gov
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
2025
Trial started· ClinicalTrials.gov
Effect of Semaglutide and Tirzepatide Combined With Exercise in Obesity
Primary completion· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
Trial started· ClinicalTrials.gov
A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese
Primary completion· ClinicalTrials.gov
Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Participants With Type 2
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fract
Results posted· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Trial started· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)
Primary completion· ClinicalTrials.gov
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
Trial started· ClinicalTrials.gov
Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity
Trial started· ClinicalTrials.gov
Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy
Primary completion· ClinicalTrials.gov
A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
Results posted· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)
Trial started· ClinicalTrials.gov
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Trial started· ClinicalTrials.gov
Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulatio
Trial started· ClinicalTrials.gov
Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
Results posted· ClinicalTrials.gov
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled W
Primary completion· ClinicalTrials.gov
A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
Trial started· ClinicalTrials.gov
Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)
Trial started· ClinicalTrials.gov
Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder
Trial started· ClinicalTrials.gov
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
Results posted· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Results posted· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)
Primary completion· ClinicalTrials.gov
Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overwe
Primary completion· ClinicalTrials.gov
Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
Trial started· ClinicalTrials.gov
Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study
Primary completion· ClinicalTrials.gov
Improving Cardiovascular Disease Diagnosis and Treatment in Kazakhstan Using Metabolic Correction With GLP-1 Drugs
Trial started· ClinicalTrials.gov
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Trial started· ClinicalTrials.gov
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obe
Primary completion· ClinicalTrials.gov
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Primary completion· ClinicalTrials.gov
A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type
Trial started· ClinicalTrials.gov
Semaglutide and Tirzepatide for Genetic Aging Delay in Adults With Obesity
Primary completion· ClinicalTrials.gov
Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction
Trial started· ClinicalTrials.gov
A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type
Trial started· ClinicalTrials.gov
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
Trial started· ClinicalTrials.gov
Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.