Orforglipron History and Updates

159 events · 2019 – present

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

1
FDA Approvals
0
Label Revisions
158
Trial Milestones
0
Pivotal Publications
Orforglipron — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20192020202120222023202420252026202720282029203020312032Trial: NCT07613307 2026-05-31 → 2027-05-31 (primary completion)Trial: NCT07241390 2025-12-01 → 2031-08-31 (primary completion)Trial: NCT07223593 2025-10-31 → 2028-06-30 (primary completion)Trial: NCT07202884 2025-09-30 → 2028-03-31 (primary completion)Trial: NCT07153471 2025-09-15 → 2028-04-30 (primary completion)Trial: NCT06972472 2025-05-19 → 2027-08-31 (primary completion)Trial: NCT06972459 2025-05-15 → 2027-08-31 (primary completion)Trial: NCT06993792 2025-05-15 → 2027-08-31 (primary completion)Trial: NCT06948422 2025-04-30 → 2027-09-30 (primary completion)Trial: NCT06952530 2025-04-30 → 2027-09-30 (primary completion)Trial: NCT06948435 2025-04-30 → 2027-09-30 (primary completion)Trial: NCT06824051 2025-02-17 → 2026-01-26 (primary completion)Trial: NCT06692348 2024-12-13 → 2025-06-09 (primary completion)Trial: NCT06704763 2024-12-06 → 2025-02-05 (primary completion)Trial: NCT06672939 2024-11-18 → 2027-12-31 (primary completion)Trial: NCT06672549 2024-11-18 → 2027-02-28 (primary completion)Trial: NCT06649045 2024-10-22 → 2026-11-30 (primary completion)Trial: NCT06584916 2024-09-13 → 2025-11-21 (primary completion)Trial: NCT06440980 2024-06-24 → 2025-06-02 (primary completion)Trial: NCT06370728 2024-05-06 → 2024-07-23 (primary completion)Trial: NCT06192108 2024-01-10 → 2025-09-26 (primary completion)Trial: NCT06186622 2024-01-02 → 2024-07-10 (primary completion)Trial: NCT06109311 2023-11-10 → 2025-09-15 (primary completion)Trial: NCT06085482 2023-10-19 → 2024-01-05 (primary completion)Trial: NCT06010004 2023-09-28 → 2025-06-05 (primary completion)Trial: NCT06045221 2023-09-22 → 2025-08-22 (primary completion)Trial: NCT06023095 2023-09-21 → 2024-07-29 (primary completion)Trial: NCT05971940 2023-08-09 → 2025-04-03 (primary completion)Trial: NCT05931380 2023-07-31 → 2025-06-19 (primary completion)Trial: NCT05936138 2023-07-13 → 2024-04-11 (primary completion)Trial: NCT05882032 2023-06-13 → 2024-11-18 (primary completion)Trial: NCT05869903 2023-06-05 → 2025-07-25 (primary completion)Trial: NCT05872620 2023-06-05 → 2025-08-08 (primary completion)Trial: NCT05841238 2023-04-26 → 2023-09-14 (primary completion)Trial: NCT05803421 2023-04-03 → 2026-03-16 (primary completion)Trial: NCT05573230 2022-10-17 → 2023-01-17 (primary completion)Trial: NCT05469126 2022-08-01 → 2022-11-03 (primary completion)Trial: NCT05313802 2022-05-26 → 2022-09-09 (primary completion)Trial: NCT05341089 2022-05-17 → 2022-09-01 (primary completion)Trial: NCT05086445 2021-11-12 → 2022-09-05 (primary completion)Trial: NCT05110794 2021-11-05 → 2022-02-10 (primary completion)Trial: NCT05051579 2021-09-29 → 2022-08-25 (primary completion)Trial: NCT05051566 2021-09-16 → 2022-04-04 (primary completion)Trial: NCT05048719 2021-09-15 → 2022-09-30 (primary completion)Trial: NCT04680767 2021-03-29 → 2021-07-03 (primary completion)Trial: NCT04426474 2020-10-08 → 2021-07-12 (primary completion)Trial: NCT03929744 2019-06-12 → 2020-11-02 (primary completion)FDA approval — 2026-04-01 FDA approved Foundayo (orforglipron) (NDA 220934) Sponsor: ELI LILLY AND CO. Class: Type 1 - New Molecular Entity.Results posted — 2023-09-13 Trial results posted: NCT05051579 A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related ComorbiditiesResults posted — 2023-10-17 Trial results posted: NCT05048719 A Study of LY3502970 in Participants With Type 2 Diabetes MellitusResults posted — 2026-04-22 Trial results posted: NCT05971940 A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise AloneResults posted — 2026-05-22 Trial results posted: NCT06186622 A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese ParticipantsResults posted — 2026-05-26 Trial results posted: NCT04680767 A Study of LY3502970 in Healthy Male ParticipantsResults posted — 2026-05-26 Trial results posted: NCT05313802 A Study of LY3502970 in Healthy Overweight and Obese ParticipantsResults posted — 2026-05-26 Trial results posted: NCT04426474 A Study of LY3502970 in Participants With Type 2 DiabetesResults posted — 2026-05-26 Trial results posted: NCT06704763 A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy ParticipantsResults posted — 2026-05-26 Trial results posted: NCT05110794 A Multiple-Dose Study of LY3502970 in Healthy ParticipantsResults posted — 2026-05-26 Trial results posted: NCT05573230 A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy ParticipantsResults posted — 2026-05-27 Trial results posted: NCT05469126 A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy ParticipantsResults posted — 2026-05-27 Trial results posted: NCT05882032 A Study of LY3502970 in Participants With Impaired and Normal Liver FunctionResults posted — 2026-05-27 Trial results posted: NCT05341089 A Study of Two Different Formulations of LY3502970 in Healthy ParticipantsResults posted — 2026-05-27 Trial results posted: NCT06085482 A Phase I Study of LY3502970 in Healthy ParticipantsResults posted — 2026-05-29 Trial results posted: NCT05051566 A Multiple Dose Study of LY3502970 in Healthy ParticipantsResults posted — 2026-06-09 Trial results posted: NCT05936138 A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants Wtoday (2026-06-10)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Orforglipron since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (24)

2026

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Primary completion· ClinicalTrials.gov
A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
Primary completion· ClinicalTrials.gov
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1
Primary completion· ClinicalTrials.gov
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
Primary completion· ClinicalTrials.gov
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Primary completion· ClinicalTrials.gov
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney D

Past events

2026
Results posted· ClinicalTrials.gov
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants W
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
Results posted· ClinicalTrials.gov
A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants
Results posted· ClinicalTrials.gov
A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
Results posted· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Primary completion· ClinicalTrials.gov
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight
2025
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney D
Primary completion· ClinicalTrials.gov
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Como
Trial started· ClinicalTrials.gov
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control W
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or With
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants
Primary completion· ClinicalTrials.gov
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
Trial started· ClinicalTrials.gov
A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Trial started· ClinicalTrials.gov
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
Trial started· ClinicalTrials.gov
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2
Trial started· ClinicalTrials.gov
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1
Primary completion· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
2024
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants
Trial started· ClinicalTrials.gov
A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
Trial started· ClinicalTrials.gov
A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Trial started· ClinicalTrials.gov
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Como
Primary completion· ClinicalTrials.gov
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
Trial started· ClinicalTrials.gov
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
Trial started· ClinicalTrials.gov
A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants
Primary completion· ClinicalTrials.gov
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants W
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control W
Trial started· ClinicalTrials.gov
A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
2023
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or With
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
Trial started· ClinicalTrials.gov
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
Results posted· ClinicalTrials.gov
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Trial started· ClinicalTrials.gov
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease
Trial started· ClinicalTrials.gov
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
Trial started· ClinicalTrials.gov
A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Trial started· ClinicalTrials.gov
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight
2022
2021
Trial started· ClinicalTrials.gov
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
2020
2019

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.