Mazdutide History and Updates

82 events · 2020 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 16, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

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 Mazdutide since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2026

Results postedMazdutide Phase 2 Trial for Obesity Shows Up to -22.3% Weight Reduction· Apr 21, 2026

2025

Primary completionMazdutide Phase 3 Trial for Type 2 Diabetes and Obesity Reaches Primary…· Sep 17, 2025
Primary completionMazdutide Phase 3 Trial for Obesity Reaches Primary Completion· Jun 27, 2025

Upcoming & expected milestones

Primary completionAug 1, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT07469800

Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

Primary completionAug 31, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06817356

A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

Primary completionSep 24, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06862908

A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT07000955

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

Primary completionDec 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06884293

A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAF

Primary completionMay 7, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06931028

A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Primary completionAug 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07417306

A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SG

Primary completionSep 30, 2027· ClinicalTrials.gov

NA primary completion: NCT07135141

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

Primary completionOct 31, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07255209

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Primary completionDec 31, 2028· ClinicalTrials.gov

NA primary completion: NCT07517042

ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

Primary completionAug 1, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT07083154

GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)

Past events

2026

Primary completionApr 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06937749

A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Trial startedApr 30, 2026· ClinicalTrials.gov

NA trial started: NCT07517042

ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

Results postedApr 21, 2026· ClinicalTrials.gov

Trial results posted: NCT06124807

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Trial registeredApr 8, 2026· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT07517042

ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

Trial startedApr 1, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07469800

Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

Trial startedMar 27, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07417306

A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SG

Trial registeredMar 13, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07469800

Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

Trial registeredFeb 18, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07417306

A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SG

2025

Primary completionDec 31, 2025· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT06519656

Efficacy of Mazdutide for Treating PCOS

Trial startedDec 29, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07255209

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Trial registeredNov 28, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07255209

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Trial startedSep 30, 2025· ClinicalTrials.gov

NA trial started: NCT07135141

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

Trial startedSep 27, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07083154

GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)

Primary completionSep 17, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT06184568

A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

Trial registeredAug 21, 2025· ClinicalTrials.gov

NA trial registered on ClinicalTrials.gov: NCT07135141

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

Trial registeredJul 24, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07083154

GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)

Primary completionJul 22, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06536023

This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

Trial startedJul 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06937749

A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Primary completionJun 27, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT06164873

A Study of IBI362 9 mg in Chinese Adults With Obesity

Trial startedJun 17, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT07000955

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

Trial startedJun 12, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06931028

A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Trial registeredJun 3, 2025· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT07000955

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

Trial startedMay 9, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06884293

A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAF

Trial registeredApr 22, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06937749

A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Trial registeredApr 16, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06931028

A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Trial startedApr 1, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06862908

A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity

Trial registeredMar 19, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06884293

A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAF

Trial registeredMar 6, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06862908

A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity

Trial registeredFeb 10, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06817356

A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

Trial startedFeb 6, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06817356

A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

Primary completionJan 22, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT06124807

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

2024

Trial startedOct 21, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT06519656

Efficacy of Mazdutide for Treating PCOS

Trial startedAug 30, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06536023

This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

Trial registeredAug 2, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06536023

This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

Trial registeredJul 25, 2024· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT06519656

Efficacy of Mazdutide for Treating PCOS

Trial startedFeb 29, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06184568

A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

Primary completionJan 26, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

2023

Trial registeredDec 28, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06184568

A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

Trial startedDec 27, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06164873

A Study of IBI362 9 mg in Chinese Adults With Obesity

Trial registeredDec 11, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06164873

A Study of IBI362 9 mg in Chinese Adults With Obesity

Trial startedNov 17, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT06124807

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Trial registeredNov 9, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06124807

A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Primary completionOct 25, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05628311

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Primary completionSep 18, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05793450

Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Primary completionAug 21, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT05607680

A Study of IBI362 in Participants With Obesity or Overweight

Primary completionAug 18, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05815680

A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subje

Trial startedMay 5, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05793450

Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Trial registeredApr 18, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05815680

A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subje

Trial startedApr 6, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05815680

A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subje

Trial registeredMar 31, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05793450

Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Primary completionMar 29, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04904913

A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Trial startedJan 6, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05628311

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Trial startedJan 6, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

2022

Trial registeredNov 28, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05628311

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Trial startedNov 14, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05607680

A Study of IBI362 in Participants With Obesity or Overweight

Trial registeredNov 7, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05607680

A Study of IBI362 in Participants With Obesity or Overweight

Trial registeredNov 7, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

Primary completionApr 28, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04965506

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

2021

Trial startedSep 6, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04965506

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Trial registeredJul 16, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04965506

A Study of IBI362 in Chinese Patients With Type 2 Diabetes

Primary completionJun 16, 2021· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04440345

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Trial startedJun 8, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04904913

A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Primary completionMay 28, 2021· ClinicalTrials.gov

Phase 1/Phase 2 primary completion: NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Trial registeredMay 27, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04904913

A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Primary completionMar 9, 2021· ClinicalTrials.gov

Phase 1 primary completion: NCT04773977

Clinical Study of IBI362 in Healthy Chinese Male Subjects

Trial startedMar 3, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04773977

Clinical Study of IBI362 in Healthy Chinese Male Subjects

Trial registeredFeb 26, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04773977

Clinical Study of IBI362 in Healthy Chinese Male Subjects

2020

Trial startedSep 12, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Trial registeredJul 10, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04466904

Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

Trial registeredJun 19, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial registered on ClinicalTrials.gov: NCT04440345

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Trial startedJun 16, 2020· ClinicalTrials.gov

Phase 1/Phase 2 trial started: NCT04440345

Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

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.