Pipeline › mazdutide
mazdutide
Not FDA-approved, and in phase 3 development, not authorised in the European Union. 12 active trials, the next due to complete 2026-09-24.
GLP-1/glucagon agonist, SC, from Innovent / Eli Lilly. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- phase3
- Target
- GLP-1/glucagon
- Route
- SC
- Sponsor
- Innovent / Eli Lilly
- First FDA approval
- Not approved
- EU authorisation
- Not authorised
- Active trials
- 12 (6 in phase 3)
- Participants enrolled
- 3,688
- Trials with a reporting date
- 6
- Approved FDA submissions
- 0
Recent changes
| Detected | Change | Trial | Detail | Phase |
|---|---|---|---|---|
| 2026-08-31 | Status changed | A Study of IBI362 9 mg in Chinese Adults With Obesity NCT06164873 · Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting → Unknown | P3 |
| 2026-08-28 | Results date moved | Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity NCT07657676 · China National Center for Cardiovascular Diseases | 2027-10-31 → 2027-12-31 2 mo later | P4 |
| 2026-08-24 | New trial registered | Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer NCT07781150 · Tongji Hospital | Not yet recruiting, n=128 | P2 |
When these trials report
Next 6 of 6 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2026-09-24 | A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity NCT06862908 · Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | Innovent Biologics (Suzhou) Co. Ltd. | P2 | 141 |
| 2027-05-07 | A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2 NCT06931028 · Change from Baseline in Apnea-Hypopnea Index (AHI) | Innovent Biologics (Suzhou) Co. Ltd. | P3 | 260 |
| 2027-08-30 | 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 · Change from baseline in Hemoglobin A1c (HbA1c) | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | P3 | 912 |
| 2027-10-31 | A Study of IBI362 in Chinese Adolescents With Obesity or Overweight NCT07255209 · Percent Change from Baseline in BMI | Innovent Biologics (Suzhou) Co. Ltd. | P3 | 180 |
| 2027-12-31 | Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity NCT07657676 · Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks | China National Center for Cardiovascular Diseases | P4 | 116 |
| 2028-06 | Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE) NCT07654062 · Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 24 | Shandong Provincial Hospital | P4 | 150 |
Indications under study
Adolescents With Obesity or Overweight With Weight-Related Comorbidities; Atypical Endometrial Hyperplasia; Coronary Heart Disease; Dementia, Mild; Endometrial Carcinoma Stage I; Endometrioid Endometrial Cancer; Heart Failure With Mildly Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction (HFPEF); Hepatic Steatosis; Hypertensive; Impaired Fasting Glucose; Impaired Glucose Tolerance (Prediabetes); Living Liver Donors; Metabolic Dysfunction-Associated Steatohepatitis; Metabolic Dysfunction-associated Steatohepatitis (MASH); Mild Cognitive Impairment; Obesity; Obesity & Overweight; Obstructive; Overweight; Prediabetes; Sleep Apnea; Type 2 Diabetes; Type 2 Diabetic Kidney Disease.