Mazdutide

Also known as: IBI362 · LY3305677

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 10 of 58 publications on PubMed
Registered clinical trials 46 26 active
Adverse event reports 0 0 classified as serious
  • Mazdutide is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 58 publications mentioning it, including 10 randomized controlled trials and 1 animal-only study.
  • ClinicalTrials.gov lists 46 registered studies testing it (26 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Glucagon-Like Peptide-1 Receptor Agonists 27
  • Obesity 27
  • Diabetes Mellitus, Type 2 23
  • Hypoglycemic Agents 22
  • Receptors, Glucagon 16
  • Weight Loss 16
  • Anti-Obesity Agents 12
  • Overweight 10
  • Glucagon-Like Peptide 1 9
  • Glucagon-Like Peptides 9

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 58
  • Human (MeSH) 37
  • Animal only 1
  • Clinical trials 10
  • Randomized controlled trials 10
  • Systematic reviews & meta-analyses 10
  • Case reports 2
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
46
Active
26
With posted results
1

Conditions studied

  • Obesity 13
  • Type 2 Diabetes 8
  • Overweight 6
  • Obesity & Overweight 2
  • Diabetes Mellitus, Type 2 2
  • Healthy 2
  • Fatty Pancreas 1
  • Atypical Endometrial Hyperplasia 1
  • Endometrial Carcinoma Stage I 1
  • Endometrioid Endometrial Cancer 1
  • Atrial Fibrillation (AF) 1
  • Ablation Treatment 1
Study Status Phase Start
Efficacy of Mazdutide on Fatty Pancreas
NCT07803705 Tongji Hospital
Not yet recruiting N/A November 15, 2026
Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer
NCT07781150 Tongji Hospital
Not yet recruiting Phase 2 November 1, 2026
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
NCT07897305 Beijing Anzhen Hospital
Not yet recruiting N/A October 25, 2026
A Study of HRS-4729 Injection in Participants With Type 2 Diabetes
NCT07843862 Fujian Shengdi Pharmaceutical Co., Ltd.
Not yet recruiting Phase 2 Oct 2026
Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial
NCT07767552 Yanbing Li
Not yet recruiting N/A September 30, 2026
Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide
NCT07713992 Tianjin Medical University
Not yet recruiting N/A September 15, 2026
Mazdutide for Weight Management and Gout in Adults With Obesity
NCT07824895 Hongwei Jiang
Not yet recruiting Phase 4 September 15, 2026
Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity
NCT07657676 China National Center for Cardiovascular Diseases
Recruiting Phase 4 September 14, 2026
Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)
NCT07718126 West China Hospital
Recruiting Phase 4 September 1, 2026
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy
NCT07775846 Huijie Zhang
Not yet recruiting Phase 4 September 1, 2026
Show 36 more studies
Study Status Phase Start
Body-weight Reduction Effect on Portal Hypertension in Compensated Cirrhosis
NCT07797101 The Second Affiliated Hospital of Chongqing Medical University
Not yet recruiting N/A September 1, 2026
Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants
NCT07765160 Innovent Biologics (Suzhou) Co. Ltd.
Not yet recruiting Phase 1 August 30, 2026
Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)
NCT07654062 Shandong Provincial Hospital
Not yet recruiting Phase 4 Jul 2026
ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
NCT07517042 Shanghai Zhongshan Hospital
Recruiting N/A June 10, 2026
GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity
NCT07633639 China-Japan Friendship Hospital
Recruiting N/A May 1, 2026
Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity
NCT07469800 Innovent Biologics (Suzhou) Co. Ltd.
Recruiting Phase 3 April 23, 2026
A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor
NCT07417306 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Not yet recruiting Phase 3 March 27, 2026
A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
NCT07255209 Innovent Biologics (Suzhou) Co. Ltd.
Recruiting Phase 3 December 29, 2025
Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity
NCT07135141 Beijing Friendship Hospital
Not yet recruiting N/A September 30, 2025
Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)
NCT07083154 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Recruiting Phase 3 September 27, 2025
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
NCT06937749 Innovent Biologics (Suzhou) Co. Ltd.
Active, not recruiting Phase 2 June 20, 2025
Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity
NCT07000955 Innovent Biologics (Suzhou) Co. Ltd.
Active, not recruiting Phase 1, Phase 2 June 17, 2025
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
NCT06931028 Innovent Biologics (Suzhou) Co. Ltd.
Recruiting Phase 3 June 12, 2025
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
NCT06884293 Innovent Biologics (Suzhou) Co. Ltd.
Active, not recruiting Phase 3 May 9, 2025
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity
NCT06862908 Innovent Biologics (Suzhou) Co. Ltd.
Active, not recruiting Phase 2 March 26, 2025
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
NCT06143956 Eli Lilly and Company
Recruiting Phase 2 November 17, 2023
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
NCT06817356 Eli Lilly and Company
Completed Phase 2 February 6, 2025
Efficacy of Mazdutide for Treating PCOS
NCT06519656 Shanghai Zhongshan Hospital
Completed Phase 1, Phase 2 October 21, 2024
This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity
NCT06536023 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 1 August 30, 2024
A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity
NCT06184568 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 3 February 29, 2024
A Study of IBI362 9 mg in Chinese Adults With Obesity
NCT06164873 Innovent Biologics (Suzhou) Co. Ltd.
Unknown status Phase 3 December 27, 2023
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
NCT06124807 Eli Lilly and Company Results posted
Completed Phase 2 November 17, 2023
Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
NCT05793450 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 1 May 5, 2023
A Study to Evaluate the Drug-drug Interactions (DDIs) of IBI362 With Metformin, Warfarin, Atorvastatin, Digoxin in Overweight or Obese Subjects
NCT05815680 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 1 April 6, 2023
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
NCT05628311 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 3 January 6, 2023
A Study of IBI362 in Participants With Type 2 Diabetes
NCT05606913 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 3 January 6, 2023
A Study of LY3305677 in Participants With Obesity Or Overweight
NCT05623839 Eli Lilly and Company
Completed Phase 1 November 16, 2022
A Study of IBI362 in Participants With Obesity or Overweight
NCT05607680 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 3 November 14, 2022
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
NCT04965506 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 2 September 6, 2021
A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
NCT04904913 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 2 June 8, 2021
Clinical Study of IBI362 in Healthy Chinese Male Subjects
NCT04773977 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 1 March 3, 2021
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
NCT04466904 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 1, Phase 2 September 12, 2020
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
NCT04440345 Innovent Biologics (Suzhou) Co. Ltd.
Completed Phase 1, Phase 2 June 16, 2020
A Study of LY3305677 in Participants With Type 2 Diabetes
NCT03928379 Eli Lilly and Company
Completed Phase 1 October 27, 2019
A Study of Multiple Doses of LY3305677 in Healthy Participants
NCT03325387 Eli Lilly and Company
Completed Phase 1 October 27, 2017
A Study of LY3305677 in Healthy Participants
NCT02972645 Eli Lilly and Company
Completed Phase 1 December 5, 2016

All 46 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.