Mazdutide: the GLORY and DREAMS phase 3 trials and its approval in China
Prepared by: Research Desk. Sources are linked for verification.
Published 30 October 2026
At a glance
- What it is: mazdutide (earlier code IBI362, also LY3305677) is a peptide that activates both the glucagon receptor and the GLP-1 receptor, developed in China by Innovent Biologics under licence from Eli Lilly
- Published phase 3 data: GLORY-1 in the New England Journal of Medicine (2025), GLORY-2 in JAMA (2026) and DREAMS-2 in Nature (2026), all run in Chinese adults
- Head-to-head: DREAMS-3 compares mazdutide with semaglutide; its design paper is published, but we found no peer-reviewed results in PubMed as of 30 October 2026
- Status: approved by China's National Medical Products Administration (NMPA) on 24 June 2025 for chronic weight management in adults; not approved in the US or EU as far as we could find
What the molecule is
Mazdutide is a synthetic peptide based on the oxyntomodulin idea: one molecule that acts on both the GLP-1 receptor and the glucagon receptor. GLP-1 receptor activity is linked to appetite and insulin secretion, while glucagon receptor activity is studied for its effects on energy expenditure and liver fat. The same dual-agonist approach is behind survodutide, which this site covered in its SYNCHRONIZE article. A fatty-acid side chain lets the trials space administrations a week apart.
GLORY-1: obesity or overweight without diabetes
GLORY-1 was a double-blind, placebo-controlled phase 3 trial in China with 610 adults who had a BMI of at least 28, or a BMI of 24 to under 28 plus at least one weight-related condition (Ji et al., 2025, PubMed). Participants were randomised 1:1:1 to two mazdutide strengths or placebo for 48 weeks. Mean baseline weight was 87.2 kg.
- Week 32 (primary end points): mean weight change was −10.09% and −12.55% with the two mazdutide strengths, against +0.45% with placebo. A loss of at least 5% was reached by 73.9%, 82.0% and 10.5% of participants respectively.
- Week 48: mean change was −11.00% and −14.01%, against +0.30% with placebo; 35.7%, 49.5% and 2.0% reached a loss of at least 15%.
- Adverse events: mostly gastrointestinal and mostly mild to moderate.
The analysis used a treatment-policy estimand, which counts every randomised participant whether or not they stopped the study drug.
GLORY-2: a stronger strength over 60 weeks
GLORY-2 tested a single, stronger mazdutide strength against placebo in 461 Chinese adults with a BMI of 30 or more, 16.1% of whom had type 2 diabetes (Gao et al., 2026, PubMed). It ran at 27 hospitals from December 2023 to November 2025, with randomisation 2:1.
- Week 60: mean weight change was −16.65% with mazdutide and −1.50% with placebo, a difference of −15.15 percentage points.
- At least 5% loss: 84.3% against 33.1%.
- Tolerability: vomiting was reported by 53.1% against 1.3%, nausea by 46.9% against 3.2%. Adverse events led 2.9% of the mazdutide group to stop, against none in the placebo group.
DREAMS-2: type 2 diabetes against dulaglutide
DREAMS-2 randomised 731 Chinese adults with type 2 diabetes on oral glucose-lowering drugs to two mazdutide strengths or dulaglutide for 28 weeks (Guo et al., 2026, PubMed). Both mazdutide strengths were non-inferior and superior to dulaglutide on HbA1c, with differences of −0.24 and −0.30 percentage points. Body-weight differences against dulaglutide were −3.78% and −5.76%.
DREAMS-3: against semaglutide
DREAMS-3 is an open-label phase 3 trial comparing mazdutide with semaglutide in 349 Chinese adults with type 2 diabetes and obesity (Luo et al., 2026, PubMed). Its primary end point combines HbA1c below 7.0% with weight loss of at least 10% at week 32. The design paper gave an expected completion in early 2026. We found no peer-reviewed results in PubMed as of 30 October 2026.
Regulatory record
According to an Innovent announcement filed with the Hong Kong stock exchange on 27 June 2025, the NMPA approved mazdutide on 24 June 2025 for chronic weight management in Chinese adults with obesity or overweight (Innovent press release). The same release said a separate application for glucose control in type 2 diabetes was under NMPA review. We found no US FDA or EMA approval.
Limitations
- Population: all four trials enrolled Chinese adults only; results may not carry over to other populations.
- Sponsor: each trial was funded by Innovent, and Innovent employees are co-authors.
- Duration: the longest published trial ran 60 weeks; long-term and cardiovascular outcome data are not yet published.
- Comparisons: results from different trials and compounds are not directly comparable because designs and populations differ.
Key terms
- Dual agonist: a single molecule that activates two different receptors
- Oxyntomodulin: a natural gut peptide that acts on both the GLP-1 and glucagon receptors
- Treatment-policy estimand: an analysis that includes every randomised participant regardless of whether they stopped the study drug
- Non-inferiority: a trial design that tests whether a new option is not worse than a comparator by more than a set margin
Supplier
Purita is a store that sells peptides for laboratory research use only. We have not checked whether it lists mazdutide; the link below goes to the store's homepage.
Affiliate disclosure: this is a paid link. KlowSignal earns a commission if a purchase is made through it, at no extra cost to the buyer. A listing is not an endorsement or a statement about product quality. See the affiliate disclosure.
Related pages
- Research peptide signals: studies and regulatory updates
- About KlowSignal
- How to read a research or regulatory signal
- Survodutide phase 3: the SYNCHRONIZE trials
- Maridebart cafraglutide (MariTide): the phase 2 paper and the MARITIME phase 3 trials
- Retatrutide phase 3: TRIUMPH-1 and TRIUMPH-2 results published
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