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.
- Human Chinese adults with obesity or overweight (GLORY-1, phase 3): in 610 adults, average weight change at the main time point was −10.1% and −12.6% on the two mazdutide arms vs +0.5% on placebo (treatment-policy). By the end of the trial it was −11.0% and −14.0% vs +0.3%. R1
- Human Chinese adults with obesity, higher-strength arm (GLORY-2, phase 3): in 461 adults, weight change was −16.7% on mazdutide vs −1.5% on placebo, and 84.3% vs 33.1% lost at least 5% of their weight. R2
- Human US adults with obesity or overweight (phase 2): in 179 adults, weight change ranged from −7.3% to −18.1% across mazdutide arms vs −0.9% on placebo. This result assumed everyone kept taking treatment, and the trial was small. R5
- Human Earlier Chinese phase 2 trial: in 248 adults, weight change ranged from −6.7% to −11.3% vs +1.0% on placebo. R6
- Unknown How mazdutide compares head-to-head with semaglutide or tirzepatide for weight. A head-to-head trial against semaglutide in Chinese adults with diabetes and obesity (DREAMS-3) has published its design; its results so far appear only in a conference abstract we have not reviewed. R9
Does it help type 2 diabetes?
- Human Diabetes on diet and exercise only (DREAMS-1, phase 3): in 320 Chinese adults, HbA1c (average blood sugar) fell 1.57 and 2.15 points on the two mazdutide arms vs 0.14 on placebo, and weight fell 5.6% and 7.8% vs 1.3%. R3
- Human Versus dulaglutide (DREAMS-2, phase 3): in 731 Chinese adults on diabetes pills, mazdutide lowered HbA1c a little more than dulaglutide (Trulicity), by 0.24 and 0.30 points more, and lowered weight by 3.8 and 5.8 points more. Stomach side effects were more common on mazdutide. R4
- Human Earlier phase 2 trial: in 250 Chinese adults, HbA1c fell 1.41 to 1.67 points on mazdutide vs 1.35 on dulaglutide and none on placebo. R7
Is it safe?
- Caution Stomach side effects were the most common problem in every trial. In GLORY-2, vomiting affected 53.1% vs 1.3% on placebo, nausea 46.9% vs 3.2%, and diarrhea 39.4% vs 6.5%. Most were mild to moderate. R2
- Caution Stopping because of side effects was uncommon in the Chinese trials (0.5% to 2.9%) but reached 20% on the highest-strength arm in the US phase 2 trial, mainly from stomach problems. R1, R2, R5
- Caution Low blood sugar: in the phase 2 diabetes trial, low blood sugar was reported in 10% on mazdutide vs 8% on placebo. Risk is likely higher for people who also take insulin or sulfonylureas (older blood-sugar-lowering pills). R7
- Caution GLP-1 class risks: mazdutide acts on the GLP-1 receptor, so the risks known for that drug class (pancreatitis, gallbladder disease, rodent thyroid tumors) are reasonable to expect; see the semaglutide page. Unknown The published abstracts we reviewed do not report rates of these events for mazdutide.
- Unknown Heart safety, long-term safety and rare harms are unknown. No heart-outcomes trial results were found.
- Unknown Older adults: very few people aged 65 or older were in the weight trials.
Compounded and gray-market mazdutide: extra risks
- Caution Unregulated "research" vials. Outside China's regulated prescription pen (Xinermei), any vial sold online as "mazdutide" is of unknown identity, strength, purity and sterility.
- Caution Don't stack with other GLP-1 drugs. Taking mazdutide together with semaglutide, tirzepatide, retatrutide or similar drugs means two drugs acting on the same receptor, which no trial on this page tested. Unknown
- Caution Measuring mistakes. FDA has reported people hospitalized after drawing up too much from multi-injection GLP-1 vials. The same syringe-marking problem applies here. See the section on measuring mistakes on our semaglutide page.
What we don't know
- Unknown Whether mazdutide lowers heart attacks, strokes or deaths
- Unknown Long-term safety, and whether weight comes back after stopping
- Unknown How well results in Chinese adults carry over to other populations (the only non-Chinese trial is a small US phase 2) R5
- Unknown Head-to-head results against semaglutide or tirzepatide in peer-reviewed form
- Unknown What is actually in a gray-market vial
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)
- Ji L, et al. N Engl J Med. 2025;392(22):2215-2225. doi:10.1056/NEJMoa2411528. PMID 40421736
- Gao L, et al. JAMA. 2026;336(5):377-388. doi:10.1001/jama.2026.8142. PMID 42251595
- Zhu D, et al. Nature. 2026;652(8108):174-180. doi:10.1038/s41586-025-10026-w. PMID 41407859
- Guo L, et al. Nature. 2026;652(8108):181-188. doi:10.1038/s41586-025-10031-z. PMID 41407860
- Hsia SH, et al. Lancet Diabetes Endocrinol. 2026;14(11):879-893. doi:10.1016/S2213-8587(26)00160-9. PMID 42628555
- Ji L, et al. Nat Commun. 2023;14(1):8289. doi:10.1038/s41467-023-44067-4. PMID 38092790
- Zhang B, et al. Diabetes Care. 2024;47(1):160-168. doi:10.2337/dc23-1287. PMID 37943529
- Shirley M. Drugs. 2025;85(12):1621-1627. doi:10.1007/s40265-025-02249-y. PMID 41028652
- Luo Y, et al. Contemp Clin Trials. 2026;160:108150. doi:10.1016/j.cct.2025.108150. PMID 41260459
- NMPA. NMPA approves mazdutide injection (notice, June 27, 2025), via ce.cn repost. https://www.ce.cn/cysc/yy/hydt/202506/t20250627_2342555.shtml
- Innovent Biologics. HKEX voluntary announcement, Sept 19, 2025. https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0919/2025091900815_c.pdf
- Innovent Biologics. Press release on mazdutide higher-strength NDA. https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=589
- 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).