← All compounds · evidence tier first, by design
| Use | E1 | E2 | E3 | E4 | E5 | E6 | E7 | E8 |
|---|---|---|---|---|---|---|---|---|
| E1 Weight reduction in obesity or overweight | E1 | |||||||
| E1 Type 2 diabetes: glycaemic control | E1 |
Mazdutide
Synthetic lipidated peptide; full structure not verified for this record.
Non-standard residues or modifications: no plain one-letter sequence
Codes: IBI362, LY3305677 · Brands: Xinermei · CAS 2259884-03-0
A synthetic peptide that activates the glucagon and GLP-1 receptors, co-developed by Innovent Biologics and Eli Lilly. A peer-reviewed drug-development review (Drugs, 2025) reports approval in China in June 2025 for long-term weight management and in September 2025 for type 2 diabetes. It is not approved in the US, EU, Canada, Australia or Japan, where it remains investigational.
- US B investigational
- EU B investigational
- UK B investigational
- CA B investigational
- AU B investigational
- JP B investigational
- CN A approved
01Regulatory status, by jurisdiction
| Jurisdiction | Status | Detail and primary source |
|---|---|---|
| US | Investigational | No Drugs@FDA application found for mazdutide (openFDA Drugs@FDA query by active ingredient returns no records). Lilly-sponsored phase 2 trials are registered on ClinicalTrials.gov.“"code": "NOT_FOUND", "message": "No matches found!"”openFDA Drugs@FDA API query: active ingredient mazdutide · retrieved 2026-10-10 |
| EU | Investigational | Mazdutide does not appear in the EMA medicines dataset (2,748 records of centrally processed medicines, timestamp 2026-10-10).“"total_records": 2748, "timestamp": "2026-10-10T06:02:36Z"”EMA medicines data (JSON report) · retrieved 2026-10-10 |
| CA | Investigational | Health Canada Drug Product Database active-ingredient query for mazdutide returns an empty result.“[]”Health Canada Drug Product Database API: active ingredient mazdutide · retrieved 2026-10-10 |
| AU | Investigational | TGA Product Information repository search for mazdutide returns no documents.“Search PI Trade Names and Active Ingredients containing mazdutide . 0 Documents available.”TGA eBS - Product and Consumer Medicine Information (search: mazdutide) · retrieved 2026-10-10 |
| JP | Investigational | Mazdutide does not appear in the PMDA List of Approved Products (New Drugs), which covers approvals through February 2026.“April 2004 to February 2026”PMDA List of Approved Products: New Drugs (April 2004 to February 2026) · retrieved 2026-10-10 |
| UK CN | Not yet verified from a primary source. No status is shown rather than an unsourced one. | |
Sport (WADA): Not prohibited. Not named on the Prohibited List. As an approved medicine it also falls outside class S0, which covers only substances without current regulatory approval: “Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development” WADA source
02What the human evidence shows
Weight reduction in obesity or overweight
n/c: not counted here; see the cited review.
GLORY-1 (phase 3, 610 Chinese adults): weight change at week 48 was -11.00% and -14.01% in the two dose groups versus +0.30% with placebo. A US phase 2 trial (179 adults, Lilly-funded) reported -7.3% to -18.1% across dose groups versus -0.9% with placebo at 32 weeks; discontinuation for adverse events reached 20% in the highest dose group.
- [1] GLORY-1: weight change -11.00% and -14.01% vs +0.30% with placebo at week 48
- [2] US phase 2: weight change -7.3% to -18.1% vs -0.9% with placebo at 32 weeks
Registered-study counts: ClinicalTrials.gov intervention search “mazdutide OR IBI362 OR LY3305677”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Type 2 diabetes: glycaemic control
n/c: not counted here; see the cited review.
Two phase 3 trials in Chinese adults. Versus placebo (320 participants, 24 weeks), HbA1c fell 1.57 and 2.15 percentage points versus 0.14. Versus the approved GLP-1 receptor agonist dulaglutide (731 participants, 28 weeks), both mazdutide doses were non-inferior and superior for HbA1c (differences -0.24 and -0.30 points) with greater weight loss. Gastrointestinal adverse events were more frequent than with dulaglutide.
- [3] HbA1c change -1.57 and -2.15 vs -0.14 points with placebo at 24 weeks
- [4] HbA1c superior to dulaglutide (differences -0.24 and -0.30 points) at 28 weeks
Registered-study counts: ClinicalTrials.gov intervention search “mazdutide OR IBI362”, fetched 2026-10-10. Registered studies include trials of other uses; the gap between registered and reported is itself a finding.
Key registered trials
| NCT | Title (as registered) | Phase | Status |
|---|---|---|---|
| NCT05607680 | A Study of IBI362 in Participants With Obesity or Overweight | 3 | Completed |
| NCT05628311 | A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise | 3 | Completed |
| NCT05606913 | A Study of IBI362 in Participants With Type 2 Diabetes | 3 | Completed |
| NCT06184568 | A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity | 3 | Completed |
| NCT06124807 | A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight | 2 | Completed |
| NCT06817356 | A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder | 2 | Completed |
03Safety signals
There are no adequate human safety data. The absence of reported harm is not evidence of safety.
- Gastrointestinal adverse events [4]
Diarrhoea, nausea and vomiting were the most common adverse events in phase 3 trials; incidence was higher than with dulaglutide in DREAMS-2. In the US phase 2 trial, discontinuation for adverse events reached 20% in the highest dose group, mainly gastrointestinal.
04What is unknown
- Cardiovascular outcomes; no cardiovascular outcome trial was located on ClinicalTrials.gov or in publications
- Efficacy and safety in non-Chinese populations beyond a single 179-participant US phase 2 trial
- Safety beyond 48 weeks of exposure, the longest duration in the published phase 3 trials
- Post-marketing safety experience in China since 2025; no surveillance data were located
- Exact wording and scope of the China approvals as issued by the NMPA, which could not be read for this record
05Product quality
No independent purity results have been published for this compound yet. The purity programme will publish full methods and vendor-named results, passes and failures, once its protocol has had legal review.
06Citations
- Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (2025). doi:10.1056/NEJMoa2411528
- Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial (2026). doi:10.1016/s2213-8587(26)00160-9
- Mazdutide versus placebo in Chinese adults with type 2 diabetes (2025). doi:10.1038/s41586-025-10026-w
- Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes (2025). doi:10.1038/s41586-025-10031-z
Every DOI is resolved against Crossref and every NCT number against ClinicalTrials.gov, title for title, before publication. Regulatory sources are cited inline above with a verbatim quote and retrieval date.
07Mechanism
Mazdutide is a peptide agonist of both the glucagon receptor and the GLP-1 receptor.
Mechanism is placed last on purpose: a plausible mechanism is not evidence that a compound works in people.
Reviewed by OSMF research team (AI-assisted, source-verified) on 2026-10-10. Found an error? It goes in the corrections log: report it.