Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-25. ← Back to Evidence Library

Mazdutide: what the evidence says

At a glance

What it is: a lab-made peptide that acts on two hormone receptors at once: GLP-1 (the target of semaglutide) and glucagon, a hormone that can raise energy use and affect liver fat. It is injected under the skin. It was developed by Innovent Biologics in China with Eli Lilly. R1, R8

What the evidence says: two phase 3 trials in China found clearly more weight loss than placebo (a dummy treatment), and two phase 3 trials in Chinese adults with type 2 diabetes found better blood-sugar control than placebo or dulaglutide (Trulicity). A smaller US phase 2 trial found similar weight loss. Every trial was funded by Innovent or Lilly, and nearly all the large ones enrolled only Chinese adults. R1, R2, R3, R4, R5

Biggest risks: stomach side effects, especially vomiting, nausea and diarrhea, which were far more common than on placebo. Long-term safety, heart outcomes and the effects of the glucagon part over many years are unknown. Gray-market vials add unknown identity, strength and purity. R2, R4, R5

Human Human evidence (weight, without diabetes) Moderate: two phase 3 RCTs (randomized controlled trials) in China, 461 and 610 people, plus a US phase 2 RCT of 179 people; all sponsor-funded; approved only in China; long-term safety unknown R1, R2, R5
Human Human evidence (type 2 diabetes, blood sugar) Moderate: two phase 3 RCTs in China (320 and 731 people), one against an approved GLP-1 drug; sponsor-funded; Chinese adults only R3, R4
Human Heart outcomes Not rated: no heart-outcomes trial results found
Human Liver disease (MASH, fatty liver with inflammation) Not rated: only animal studies and conference abstracts found; no peer-reviewed human liver trial results
Animal Animal evidence Not rated here
Regulatory Not FDA-approved (no Drugs@FDA record) · Approved in China for weight management, June 2025, and type 2 diabetes, Sept 2025 (confirmed in Adis Drugs R8 and HKEX/ce.cn notices R10, R11; <span class="tag unverified">UNVERIFIED</span> direct on nmpa.gov.cn due to host block) · EU, Japan: UNVERIFIED not checked against EMA or PMDA · WADA: not named R13
Established human dose Approved in China only. The Chinese label is not reproduced here. Trial study arms are listed only in Study details

Evidence verdict: Human (weight): Moderate · Human (type 2 diabetes): Moderate · Heart outcomes: not rated · Liver: not rated · Animal: not rated here Card verdict: Moderate (weight loss & type 2 diabetes in Chinese phase 3 trials; approved in China, not FDA-approved)

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source


What is it?

Mazdutide (also called IBI362 or LY3305677) is a lab-made peptide that activates two receptors: the GLP-1 receptor, which lowers appetite and blood sugar, and the glucagon receptor. R1, R8 Glucagon normally raises blood sugar, but drug makers are testing it alongside GLP-1 because it may increase the energy the body burns and reduce liver fat. Unknown How much the glucagon part adds in people, compared with GLP-1 action alone, has not been tested directly in a published trial.

Retatrutide and survodutide are other drugs in development that also act on the glucagon receptor; see the retatrutide page and the survodutide page.

Does it help weight loss?

All results below come from trials funded by Innovent Biologics or Eli Lilly. "Treatment-policy" results count everyone, whether or not they kept taking the drug, which gives a more realistic picture.

Does it help type 2 diabetes?

Is it safe?

Compounded and gray-market mazdutide: extra risks

What we don't know

Is it legal?

Not FDA-approved; no Drugs@FDA record was found (openFDA search, Oct 24, 2026). China: NMPA approved mazdutide injection (Xinermei, Innovent Biologics) on June 24, 2025 for long-term weight management in adults with obesity, or overweight with at least one weight-related condition. R10 [UNVERIFIED: read from the NMPA notice as republished by ce.cn and from NMPA's own innovative-drug list as shown in a search index; nmpa.gov.cn blocked a direct fetch.] A second approval for blood-sugar control in adults with type 2 diabetes was announced in September 2025. R8, R11 [UNVERIFIED: company filing and review article, not checked on nmpa.gov.cn.] Innovent has also announced a filing for a higher-strength version. R12 [UNVERIFIED: company statement.] EU, Japan and other countries: UNVERIFIED not checked against EMA or PMDA. WADA: not named on the 2026 Prohibited List, and S0 covers only substances with no current approval anywhere R13. As of Oct 24, 2026.

What's in the vial?

Real mazdutide comes as a prefilled pen made by Innovent and sold in China, or inside clinical trials. R10 We have not found published lab tests of gray-market mazdutide. Under the Open Peptide Standard, a GLP-1 vial overfilled by more than 20% is a critical fail (draft threshold). See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.

What do users report?

Self-report, not evidence.

Unknown TBD. We'll only list this once we can cite a public source.

Study details

These are doses researchers used, not recommendations. All trials funded by Innovent Biologics or Eli Lilly. All injections subcutaneous, once weekly unless noted.

R1, R2, R5, R6 Human: Weight trials (GLORY and phase 2)

Study People Route Dose used Follow-up Reported Side effects / dropouts Citation
GLORY-1 (Ji 2025), China, obesity/overweight, NCT05607680 610 (1:1:1) Subcutaneous Mazdutide 4 mg or 6 mg once weekly vs placebo 32 wk primary; 48 wk Wk 32: −10.09% (4 mg), −12.55% (6 mg) vs +0.45%; wk 48: −11.00%, −14.01% vs +0.30% (treatment-policy); ≥15% loss at wk 48: 35.7%, 49.5% vs 2.0% Mostly GI, mild/moderate; stopped for AEs 1.5%, 0.5% vs 1.0% PMID 40421736
GLORY-2 (Gao 2026), China, BMI ≥30, NCT06164873 461 treated (307 vs 154) Subcutaneous Mazdutide 9 mg once weekly vs placebo + diet/activity 60 wk −16.65% vs −1.50% (difference −15.15%); ≥5% loss 84.3% vs 33.1% Vomiting 53.1% vs 1.3%; nausea 46.9% vs 3.2%; diarrhea 39.4% vs 6.5%; stopped for AEs 2.9% vs 0% PMID 42251595
US phase 2 (Hsia 2026), NCT06124807 179 (32 / 48 / 51 vs 48) Subcutaneous Mazdutide 3 mg then 6 mg from wk 32, 10 mg, or 16 mg once weekly vs placebo 32 wk primary; 48 wk Wk 32: −7.3%, −15.6%, −18.1% vs −0.9% (efficacy estimand) Mostly GI; stopped for AEs highest with 16 mg (20%); Lilly-funded PMID 42628555
China phase 2 (Ji 2023), NCT04904913 248 Subcutaneous Mazdutide 3, 4.5 or 6 mg once weekly vs placebo 24 wk (interim) −6.7%, −10.4%, −11.3% vs +1.0% Diarrhea, nausea, URTI most common PMID 38092790

R3, R4, R7, R9 Human: Type 2 diabetes trials (DREAMS and phase 2)

Study People Route Dose used Follow-up Reported Side effects / dropouts Citation
DREAMS-1 (Zhu 2026), diet/exercise only, NCT05628311 320 (1:1:1) Subcutaneous Mazdutide 4 mg or 6 mg once weekly vs placebo 24 wk + 24 wk extension HbA1c −1.57, −2.15 vs −0.14; weight −5.61%, −7.81% vs −1.26% Diarrhea, decreased appetite, nausea most common PMID 41407859
DREAMS-2 (Guo 2026), on oral drugs, NCT05606913 731 (1:1:1) Subcutaneous Mazdutide 4 mg or 6 mg once weekly vs dulaglutide 1.5 mg 28 wk HbA1c difference vs dulaglutide −0.24 (p=0.0032), −0.30 (p=0.0003); weight difference −3.78%, −5.76% GI events more frequent than dulaglutide PMID 41407860
Phase 2 T2D (Zhang 2024) 250 (51/49/49 mazdutide, 50 dulaglutide, 51 placebo) Subcutaneous Mazdutide 3, 4.5 or 6 mg vs dulaglutide 1.5 mg (open-label) vs placebo 20 wk HbA1c −1.41 to −1.67 vs −1.35 dulaglutide, +0.03 placebo; weight up to −7.1% Diarrhea 36%, decreased appetite 29%, nausea 23%, vomiting 14%, hypoglycemia 10% (8% placebo) PMID 37943529
DREAMS-3 design (Luo 2026), vs semaglutide, open-label 349 Subcutaneous Mazdutide 6 mg vs semaglutide 1 mg once weekly 32 wk + 24 wk extension Unknown design/baseline only in this paper; results in ADA 2026 abstract 1226-OR (not reviewed) Not reported PMID 41260459

R8, R10–R12 Regulatory (as of Oct 24, 2026)

  • R10 NMPA notice "国家药监局批准玛仕度肽注射液上市" (NMPA approves mazdutide injection), June 27, 2025, approval date June 24, 2025, Innovent Biologics (Suzhou), class 1 innovative drug, indication long-term weight management (BMI ≥28, or ≥24 with a weight-related comorbidity). Read via ce.cn repost, source marked NMPA website and the title in NMPA's innovative-drug list as shown in a search index. UNVERIFIED Direct fetch of nmpa.gov.cn returned a script-protected blank page.
  • R11 Innovent Biologics HKEX voluntary announcement, Sept 19, 2025: NMPA approval for glycemic control in adults with type 2 diabetes, based on DREAMS-1 and DREAMS-2. UNVERIFIED Company source.
  • R8 Shirley M, "Mazdutide: First Approval," Drugs 2025 (review; not a regulator): first approval in China, June 2025; type 2 diabetes approval Sept 2025.
  • R12 Innovent press release on a mazdutide 9 mg NDA (source index row; link). UNVERIFIED Not checked on nmpa.gov.cn; outcome unknown.
  • FDA: no Drugs@FDA record (openFDA query, Oct 24, 2026). EMA, PMDA: UNVERIFIED not checked.

Full reference list (all PMIDs verified on PubMed, Oct 24, 2026)

  1. Ji L, et al. N Engl J Med. 2025;392(22):2215-2225. doi:10.1056/NEJMoa2411528. PMID 40421736
  2. Gao L, et al. JAMA. 2026;336(5):377-388. doi:10.1001/jama.2026.8142. PMID 42251595
  3. Zhu D, et al. Nature. 2026;652(8108):174-180. doi:10.1038/s41586-025-10026-w. PMID 41407859
  4. Guo L, et al. Nature. 2026;652(8108):181-188. doi:10.1038/s41586-025-10031-z. PMID 41407860
  5. Hsia SH, et al. Lancet Diabetes Endocrinol. 2026;14(11):879-893. doi:10.1016/S2213-8587(26)00160-9. PMID 42628555
  6. Ji L, et al. Nat Commun. 2023;14(1):8289. doi:10.1038/s41467-023-44067-4. PMID 38092790
  7. Zhang B, et al. Diabetes Care. 2024;47(1):160-168. doi:10.2337/dc23-1287. PMID 37943529
  8. Shirley M. Drugs. 2025;85(12):1621-1627. doi:10.1007/s40265-025-02249-y. PMID 41028652
  9. Luo Y, et al. Contemp Clin Trials. 2026;160:108150. doi:10.1016/j.cct.2025.108150. PMID 41260459
  10. NMPA. NMPA approves mazdutide injection (notice, June 27, 2025), via ce.cn repost. https://www.ce.cn/cysc/yy/hydt/202506/t20250627_2342555.shtml
  11. Innovent Biologics. HKEX voluntary announcement, Sept 19, 2025. https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0919/2025091900815_c.pdf
  12. Innovent Biologics. Press release on mazdutide higher-strength NDA. https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=589
  13. WADA. World Anti-Doping Code International Standard: Prohibited List 2026 (in force Jan 1, 2026). https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf (text read Oct 24, 2026)

Disclaimer

This page is for education and harm reduction. It is not medical advice and not a recommendation to use mazdutide. Please talk to a clinician you trust before making medical decisions, seek care right away for severe stomach pain or repeated vomiting, and report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).