Retatrutide History and Updates

104 events · 2019 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

104

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG

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

All published updates (6)

2026

Primary completionRetatrutide Phase 3 Trial for Obesity and Overweight Completes Primary Study· Apr 30, 2026
Primary completionRetatrutide Phase 3 Trial for Obesity and CVD Reaches Primary Completion· Apr 30, 2026
Primary completionRetatrutide Phase 3 Study for Obesity and CVD Reaches Primary Completion· Apr 16, 2026
Primary completionRetatrutide Phase 3 Study for Obesity or Overweight Reaches Primary Completion· Apr 6, 2026
Primary completionRetatrutide Phase 3 Trial for Type 2 Diabetes Completes Primary Data Collection· Jan 22, 2026

2025

Primary completionRetatrutide Phase 3 Trial for Obesity and Knee OA Completes Primary Study Period· Nov 14, 2025

Upcoming & expected milestones

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06260722

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin Wi

Primary completionOct 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06297603

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Gl

Primary completionNov 30, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06982859

A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellit

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06662383

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Primary completionMar 14, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07467447

Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight

Primary completionJul 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07232719

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

Primary completionSep 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07035093

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Primary completionApr 30, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06859268

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Primary completionOct 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07357415

A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight

Primary completionFeb 28, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06383390

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

Primary completionAug 31, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT07165028

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Past events

2026

Trial registeredJun 5, 2026· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07629401

Provide Pre-approval Expanded Access of LY3437943

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05929079

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 1 primary completion: NCT06982846

A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05929066

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05882045

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Primary completionApr 16, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05882045

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Primary completionApr 6, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05929066

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Trial registeredMar 12, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07467447

Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight

Trial startedFeb 15, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07467447

Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight

Trial startedJan 24, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07357415

A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight

Trial registeredJan 22, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07357415

A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight

Primary completionJan 22, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06354660

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercis

2025

Trial registeredNov 18, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07232719

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

Trial startedNov 17, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07232719

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

Primary completionNov 14, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05931367

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

Trial startedOct 15, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07165028

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Primary completionOct 1, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05936151

A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without T

Trial registeredSep 10, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07165028

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Primary completionAug 26, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06313528

A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

Trial registeredJun 24, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07035093

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Trial startedJun 6, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06982846

A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

Trial startedJun 2, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06982859

A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellit

Trial startedMay 29, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07035093

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Trial registeredMay 21, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06982859

A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellit

Trial registeredMay 21, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06982846

A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

Primary completionApr 15, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06808802

To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants

Trial registeredMar 5, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06859268

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Trial startedMar 5, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06859268

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Primary completionMar 2, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT05916560

A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Trial registeredFeb 5, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06808802

To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants

Trial startedFeb 3, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT06808802

To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants

2024

Trial startedNov 1, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06662383

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Trial registeredOct 28, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06662383

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Primary completionJul 25, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05959096

A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Primary completionJul 11, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06039826

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Trial startedApr 30, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06383390

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

Trial registeredApr 25, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06383390

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

Trial startedApr 10, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06354660

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercis

Trial registeredApr 9, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06354660

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercis

Trial startedMar 20, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06313528

A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

Trial registeredMar 15, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06313528

A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

Trial startedMar 15, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06297603

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Gl

Trial registeredMar 7, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06297603

Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Gl

Trial startedFeb 21, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06260722

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin Wi

Trial registeredFeb 15, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06260722

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin Wi

Primary completionFeb 8, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06003465

A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

2023

Trial registeredSep 15, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06039826

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Results postedSep 13, 2023· ClinicalTrials.gov

Trial results posted: NCT04881760

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

Trial startedSep 12, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06039826

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Primary completionSep 5, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05611957

A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

Trial startedAug 29, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06003465

A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

Trial registeredAug 22, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06003465

A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

Trial startedAug 1, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05931367

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

Primary completionJul 27, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05548231

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Trial registeredJul 25, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05959096

A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Trial startedJul 20, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05936151

A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without T

Trial startedJul 18, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05959096

A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Trial startedJul 13, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05916560

A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Trial startedJul 11, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05929079

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Trial startedJul 10, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05929066

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Trial registeredJul 7, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05936151

A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without T

Trial registeredJul 5, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05931367

A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

Results postedJul 3, 2023· ClinicalTrials.gov

Trial results posted: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Trial registeredJul 3, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05929079

A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Trial registeredJul 3, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05929066

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Primary completionJun 23, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05757531

A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male Participants

Trial registeredJun 23, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05916560

A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Trial registeredMay 31, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05882045

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Trial startedMay 30, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05882045

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Trial startedMar 17, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05757531

A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male Participants

Trial registeredMar 7, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05757531

A Study of Carbon-14-Labelled [14C] LY3437943 in Healthy Male Participants

Primary completionFeb 24, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05445232

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

2022

Trial startedNov 16, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05611957

A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

Trial registeredNov 10, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05611957

A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

Trial startedOct 24, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05548231

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Trial registeredSep 21, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05548231

A Study of LY3437943 in Chinese Participants With Obesity Or Overweight

Primary completionJul 8, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Trial startedJul 8, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05445232

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

Trial registeredJul 6, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05445232

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

Primary completionJun 23, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT04823208

A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

Primary completionMay 16, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04881760

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

2021

Trial startedMay 24, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04823208

A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

Trial startedMay 20, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04881760

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

Trial startedMay 13, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Trial registeredMay 11, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04881760

A Study of LY3437943 in Participants Who Have Obesity or Are Overweight

Trial registeredApr 30, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

Trial registeredMar 30, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04823208

A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

2020

Primary completionDec 28, 2020· ClinicalTrials.gov

Phase 1 primary completion: NCT04143802

A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

2019

Trial startedDec 18, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT04143802

A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

Trial registeredOct 29, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04143802

A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

Primary completionJul 25, 2019· ClinicalTrials.gov

Phase 1 primary completion: NCT03841630

A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

Trial startedMar 13, 2019· ClinicalTrials.gov

Phase 1 trial started: NCT03841630

A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

Trial registeredFeb 15, 2019· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03841630

A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

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.