Mazdutide: what the evidence shows

What the human research shows

Grade A on weight because the phase 3 trials are large, published and consistent — but the approval is Chinese only, the trials enrolled Chinese adults, and no Western regulator has reviewed it. Outside China it is an investigational drug, whatever the vial says.

Evidence profile0–5

Metabolic & weightA5.0
Cardiovascular—0.0
Muscle & growth—0.0
Healing & repair—0.0
Neuro & sleep—0.0
Immune & inflammation—0.0
Sexual & hormonal—0.0
Skin & appearance—0.0
Ageing & longevity—0.0

Each score is confidence × effect size, taken from the best-evidenced benefit in that domain: the grade (A–D) sets the confidence, the measured effect sets the size. Hover a domain to see the outcomes behind it. Adverse effects are excluded and listed separately below.

Outcome	Grade	Effect size	Human studies	Where the evidence comes from
Body weight	AEstablished	Large	2 phase 3 RCTs	GLORY-1, 610 Chinese adults, 48 weeks: −12.0% (4 mg) and −14.8% (6 mg) versus −0.5% placebo; at least 5% loss in 73.5%, 82.8% and 11.5%. GLORY-2, 461 adults, 60 weeks on 9 mg: −16.65% versus −1.50%; 84.3% versus 33.1% lost at least 5%.1 2
Liver fat	BProbable	Large	Phase 3 sub-analyses	Among participants with baseline liver fat above 10%: −66% (4 mg) and −80% (6 mg) versus −5% in GLORY-1; −72% versus +5% in GLORY-2.1 2
Blood glucose (HbA1c)	AEstablished	Moderate	DREAMS phase 3 programme	DREAMS-1 and DREAMS-2 in type 2 diabetes met their HbA1c endpoints; approved for glycaemic control in China on that basis. DREAMS-3 reported superiority to semaglutide on HbA1c and weight.3
GI side effectsadverse	AEstablished	Moderate	Phase 3	Nausea, diarrhoea and vomiting were the most frequent adverse events, mostly mild to moderate; discontinuation for adverse events 2.9% versus 0% in GLORY-2.1 2

AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 3 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

Registered trials

ClinicalTrials.gov lists 43 interventional studies naming Mazdutide as an intervention — 18 completed, 10 recruiting, and 1 with results posted to the registry.

A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.

Study	Phase	Status	Participants	Sponsor	Results
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or OverweightNCT06124807 · started Nov 2023	Phase 2	Completed	179	Eli Lilly and Company	Posted
QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic NephropathyNCT07775846 · started Sept 2026	Phase 4	Not yet recruiting	820*	Huijie Zhang	None
Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)NCT07654062 · started Jul 2026	Phase 4	Not yet recruiting	150*	Shandong Provincial Hospital	None
Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or ObesityNCT07657676 · started Sept 2026	Phase 4	Recruiting	116*	China National Center for Cardiovascular Diseases	None
Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)NCT07718126 · started Sept 2026	Phase 4	Recruiting	60*	West China Hospital	None
Mazdutide for Weight Management and Gout in Adults With ObesityNCT07824895 · started Sept 2026	Phase 4	Not yet recruiting	30*	Hongwei Jiang	None
A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) InhibitorNCT07417306 · started Mar 2026	Phase 3	Not yet recruiting	912*	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.	None
A Study of IBI362 in Participants With Type 2 DiabetesNCT05606913 · started Jan 2023	Phase 3	Completed	731	Innovent Biologics (Suzhou) Co. Ltd.	None

35 further studies are registered. Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.

What it is

An oxyntomodulin analogue engineered for weekly dosing, originally discovered by Lilly and developed in China by Innovent. Sold in China under the brand Xinermei (信尔美) at 4 mg and 6 mg since mid-2025, with a 9 mg dose in review.

It is the first dual GLP-1/glucagon agonist approved anywhere, which makes its Chinese trials the best published evidence for the mechanism — with the caveat that every participant was Chinese and the results may not transfer unchanged to other populations.

How it is thought to work

The GLP-1 half suppresses appetite and slows gastric emptying; the glucagon half raises energy expenditure and clears liver fat. The unusually large liver-fat reductions in GLORY-1 and GLORY-2 are the signature of the second mechanism.

What is still unknown

Whether Lilly, which holds rights outside China, will take it through Western phase 3 trials.
Cardiovascular outcomes — no outcome trial exists.
How it performs in non-Chinese populations.

The molecule and how long it lasts

Identity

Formula: C207H317N45O65
Molecular weight: 4476 g/mol
CAS number: 2259884-03-0
PubChem: CID 167312357

PubChem record, read 23 September 2026.

Pharmacokinetics

Route: Subcutaneous, once weekly
Half-life: About a week or longer — reported as 7 to 45 days across doses in the phase 1b trial

From a published human pharmacokinetic study: Ji L, et al. Safety and efficacy of the GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) in Chinese adults with overweight or obesity: a phase 1b trial. eClinicalMedicine 2022

Regulatory status

European Union

Not authorised

No EMA application. Products sold online as mazdutide are unauthorised medicines.

United States

Not approved; cannot be compounded

Phase 2 in the US. The FDA has warned companies selling 'research' mazdutide for human use; it cannot be compounded.

United Kingdom

Unlicensed

No MHRA licence; supply is an offence.

Australia

Unapproved

Not on the ARTG; prescription-only substance with no lawful supply.

Canada

Not authorised

No DIN.

Sport (WADA)

Not on the list

Approved by China's NMPA, so S0 does not apply; not named in any section. Athletes should check the annual list.

Questions people actually ask

Is mazdutide approved?

In China, yes — for chronic weight management since 27 June 2025 and for type 2 diabetes since later that year. Nowhere else. In the US, EU, UK, Australia and Canada it is an unapproved drug.

How does mazdutide compare with tirzepatide?

No head-to-head trial exists. GLORY-2's 16.7% at 60 weeks on 9 mg sits between semaglutide's and tirzepatide's own trial results, but cross-trial comparison is unreliable — different populations, durations and placebo responses.

Can I buy mazdutide online?

Not legally outside China, and the FDA has specifically named it in warning letters to research-chemical sellers. What arrives in a vial is unverified.

One page per claimed effect

ADoes Mazdutide help with body weight?2 phase 3 RCTs
BDoes Mazdutide help with liver fat?Phase 3 sub-analyses
ADoes Mazdutide help with blood glucose?DREAMS phase 3 programme
AHow common is GI side effects with Mazdutide?Phase 3

References

1
Ji L, et al. Once-weekly mazdutide in Chinese adults with obesity or overweight (GLORY-1).N Engl J Med, 2025; DOI 10.1056/NEJMoa2411528610 adults, 48 weeks.
2
Gao L, et al. Treatment with 9-mg mazdutide for weight reduction in Chinese adults with obesity: the GLORY-2 randomized clinical trial.JAMA, 2026;336:377–388461 adults, 60 weeks on 9 mg; −16.65% versus −1.50%.
3
Innovent. Mazdutide received approval from China's NMPA for chronic weight management; DREAMS programme in type 2 diabetes.Press releases, 2025Approval 27 June 2025.
4
Mazdutide: first approval.Drugs, 2025Regulatory summary.

Change log

2026-09-03Initial publication from GLORY-1 and GLORY-2 (both peer-reviewed) and the NMPA approvals.