Mazdutide: Weight-Loss Results, Approval Status, and US Availability
Mazdutide is a dual glucagon/GLP-1 drug approved in China for weight management and type 2 diabetes, not by the FDA. In the Phase 3 GLORY-2 study, the 9 mg dose produced 18.55% mean weight loss over 60 weeks versus 3.02% for placebo.
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Mazdutide is a dual glucagon (GCG)/GLP-1 receptor agonist that China’s National Medical Products Administration (NMPA) has approved for two uses: chronic weight management and glycemic control in adults with type 2 diabetes [1][2]. It is not approved by the US Food and Drug Administration, and no FDA submission, review, or US marketing of the drug has been announced [1][2]. In its headline Phase 3 obesity trial, GLORY-2, people taking mazdutide 9 mg lost an average of 18.55% of their body weight over 60 weeks, compared with 3.02% for placebo [1]. Innovent Biologics, the company behind the drug, states plainly that it “does not recommend the use of any unapproved drug(s)/indication(s)” [1].
What is mazdutide and how does it work?
Mazdutide is described as a first-in-class dual glucagon (GCG)/GLP-1 receptor agonist, meaning it activates two receptors at once: the GLP-1 receptor and the glucagon receptor [1][2].
The molecule is a mammalian oxyntomodulin (OXM) analog [1]. According to Innovent, beyond the usual GLP-1 effects on insulin secretion, blood glucose, and body weight, activating the glucagon receptor may also increase energy expenditure and improve hepatic fat metabolism [1]. Innovent also reports that in clinical studies mazdutide reduced waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, and liver fat content, and improved insulin sensitivity [1].
In trial registries, the drug appears under development codes: IBI362 (Innovent’s code) and LY3305677 (Lilly’s code) [3][5][6]. Innovent calls mazdutide the world’s first dual GCG/GLP-1 receptor agonist approved for glycemic control in adults with type 2 diabetes [2]. Innovent describes the approved injection device in China as having a hidden needle, a single-use design, and what the company calls X-cross-section technology [2].
Who makes mazdutide, and what is Eli Lilly’s role?
Mazdutide is developed and commercialized in China by Innovent Biologics (HKEX: 01801), a biopharmaceutical company based in Suzhou, China, founded in 2011 [1][2]. Innovent holds an exclusive license from Eli Lilly and Company for development and potential commercialization of mazdutide in China [1][2]. Nothing in the companies’ statements says Lilly holds rights outside China, and no filing plan or portfolio decision for the drug elsewhere has been announced.
Innovent has launched 16 products and partners with more than 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem, and MD Anderson Cancer Center [1].
Trial registries list additional studies under these drug codes: a study of LY3305677 compared with placebo in adult participants with obesity or overweight (NCT06124807), a study of mazdutide compared with placebo in participants with alcohol use disorder (NCT06817356), and a master protocol study (LY900038) of multiple intervention-specific appendices in adult participants with obesity or overweight (NCT06143956) [3][4][8]. The registry titles show the drug codes and study topics.
How much weight did people lose in the GLORY-2 study?
GLORY-2 (NCT06164873) was a Phase 3 study of mazdutide 9 mg plus lifestyle intervention versus placebo in Chinese adults with obesity, defined as BMI ≥30 kg/m² [1]. It enrolled 462 participants, 16% of whom had type 2 diabetes, randomized 2:1 to mazdutide or placebo across a 60-week double-blind treatment period [1]. Mean baseline weight was 94.0 kg and mean baseline BMI was 34.3 kg/m² [1].
| GLORY-2 result at Week 60 | Mazdutide 9 mg | Placebo |
|---|---|---|
| Mean weight reduction (all participants) | 18.55% | 3.02% |
| Lost ≥20% of body weight (all participants) | 44.0% | 2.6% |
| Mean weight reduction (participants without T2D) | 20.08% | 2.81% |
| Lost ≥20% of body weight (without T2D) | 48.7% | 3.1% |
Innovent reported P<0.0001 for the comparisons of participants achieving a weight reduction of 20% or more, in both the overall study and the subgroup without type 2 diabetes [1]. Note that the 20.08% figure applies only to the subgroup without type 2 diabetes; the whole-trial average was 18.55% [1]. Innovent reported no weight-loss plateau at Week 60 [1].
The study also measured liver fat with MRI-PDFF in a subset. Among participants without type 2 diabetes whose baseline liver fat was ≥10%, liver fat fell 71.9% from baseline in the mazdutide group by Week 60, while it rose 5.1% in the placebo group [1]. All key secondary endpoints were met, including waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and serum uric acid [1].
The results were announced on November 19, 2025, and Innovent said it plans to submit a new drug application for mazdutide 9 mg for weight management to China’s Center for Drug Evaluation (CDE) of the NMPA [1]. Dr. Lei Qian, Innovent’s Chief R&D Officer of General Biomedicine, claimed mazdutide 9 mg is “currently the only GLP-1 receptor agonist that achieves over 20% weight loss in obese adults without T2D after 1 year of treatment with just a 2-step dose titration” [1]. That is a company claim, not an independent finding.
What did the diabetes trials show?
China’s type 2 diabetes approval, announced September 19, 2025, was based on two Phase 3 trials: DREAMS-1 (NCT05628311), testing mazdutide as monotherapy, and DREAMS-2 (NCT05606913), testing it in combination with oral antidiabetic drugs [2].
| Result | Mazdutide 4 mg | Mazdutide 6 mg | Comparator |
|---|---|---|---|
| DREAMS-1, HbA1c change at Week 24 | −1.57% | −2.15% | −0.14% (placebo) |
| DREAMS-1, HbA1c <7% | 68.6% | 87.4% | 10.7% (placebo) |
| DREAMS-1, weight change | −5.61% | −7.81% | −1.26% (placebo) |
| DREAMS-2, HbA1c change at Week 28 | −1.69% | −1.73% | −1.38% (dulaglutide 1.5 mg) |
| DREAMS-2, weight change | −7.31% | −9.24% | −2.86% (dulaglutide 1.5 mg) |
| DREAMS-2, HbA1c <7% plus ≥5% weight loss | 50.1% | 64.3% | 19.4% (dulaglutide 1.5 mg) |
Innovent states these studies demonstrated mazdutide’s superiority over placebo or dulaglutide 1.5 mg in glycemic control and weight reduction, along with improvements in cardiometabolic, hepatic, and renal parameters [2]. DREAMS-1 results were presented orally at the 85th Scientific Sessions of the American Diabetes Association (Abstract 306-OR), and DREAMS-2 was presented as a late-breaking oral at the 60th Annual Meeting of the European Association for the Study of Diabetes (Abstract LBA 16) [2].
How does mazdutide compare with semaglutide?
Head-to-head Phase 3 studies against semaglutide exist, but the announcements cited here do not report the comparative numbers. DREAMS-3 is a Phase 3 study comparing mazdutide versus semaglutide in Chinese adults with type 2 diabetes and obesity, and it is one of the first five Phase 3 studies of mazdutide that met their primary endpoints [1]. A registry entry for a study comparing IBI362 versus semaglutide in Chinese adults with early type 2 diabetes and obesity is listed as NCT06184568 [5]. GLORY-3, comparing mazdutide versus semaglutide 2.4 mg in Chinese adults with overweight or obesity plus metabolic-associated fatty liver disease, is still ongoing [1].
Two cautions apply. First, the announcements cited here do not give the head-to-head numbers, so no conclusion about which drug performed better can be drawn from them. Second, all of these trials were conducted in Chinese adults, and China’s weight-management approval threshold is BMI ≥28 kg/m², while GLORY-2 enrolled people with BMI ≥30 kg/m² [1]. Comparing mazdutide’s numbers directly with US trial results for other drugs would treat different populations as equivalent, which they are not.
What doses and conditions are on the approved China label?
For weight management, mazdutide is approved in China as an adjunct to a reduced-calorie diet and increased physical activity for adults with a BMI ≥28 kg/m² (obesity), or a BMI ≥24 kg/m² (overweight) with at least one weight-related comorbidity such as hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome [1].
For type 2 diabetes, it is approved as monotherapy for adults with inadequate glycemic control despite diet and exercise, and in combination with metformin and/or sulfonylureas, or metformin and/or SGLT2 inhibitors, for adults still poorly controlled on those regimens [2].
The doses studied were 4 mg and 6 mg in the type 2 diabetes trials and 9 mg in the obesity trial, with the 9 mg weight-management application planned for submission in China [1][2]. The companies’ announcements do not specify how often the drug is injected or how dosing is titrated, so no dosing schedule is described here.
What side effects were reported?
In GLORY-2, the majority of gastrointestinal adverse events were mild to moderate and transient, and Innovent reported no new safety signals [1]. Discontinuation due to adverse events occurred in 2.9% of the mazdutide 9 mg group and 0% of the placebo group [1].
In the type 2 diabetes program, Innovent states the safety profile was consistent with previous clinical studies and other GLP-1 receptor agonists, with no new safety signals identified [2].
These findings come from company announcements about Chinese trials. No FDA-reviewed prescribing information exists for mazdutide, so there is no US label documenting warnings, contraindications, or drug interactions, and the FDA has published a page titled “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” [9].
Why isn’t mazdutide available in the US?
The only approval announced is from China’s NMPA, and it rests entirely on Phase 3 data from Chinese participants [1][2].
The scale of the disease burden behind the China approval is large. According to the 2021 International Diabetes Federation overview cited by Innovent, China has about 140 million adults with diabetes, roughly 1 in 4 global cases, projected to reach 174 million by 2045 [2]. The ADA/EASD consensus report on managing hyperglycemia in type 2 diabetes recognizes weight reduction as a core therapeutic target, with a 5%–15% body weight reduction recommended as a primary goal for some patients [2].
Is it safe to buy mazdutide online or labeled “research use”?
The FDA publishes a dedicated page titled “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” [9]. Because mazdutide has no FDA approval, there is no FDA-reviewed prescribing information for it — no US label documenting dosing, warnings, or drug interactions [9]. Innovent’s approved product is distributed in China under NMPA-approved indications, and the company explicitly disclaims unapproved use of its drugs [1].
What else is being studied?
Innovent has conducted or completed seven Phase 3 studies of mazdutide: GLORY-1 in Chinese adults with overweight or obesity; GLORY-2 in Chinese adults with moderate-to-severe obesity; DREAMS-1 and DREAMS-2 in type 2 diabetes; DREAMS-3 versus semaglutide; GLORY-3 versus semaglutide 2.4 mg in overweight or obesity with fatty liver disease; and GLORY-OSA in obstructive sleep apnea with obesity [1]. The first five met their primary endpoints; the remaining two are ongoing [1].
According to Innovent, additional studies of mazdutide are ongoing in adolescents with obesity, metabolic dysfunction-associated steatohepatitis (MASH), and heart failure with preserved ejection fraction [1]; the adolescent study is registered as NCT07255209 [6]. Separately, a trial registry entry lists a study of mazdutide versus placebo in participants with alcohol use disorder (NCT06817356) [8]. Mazdutide findings have appeared in The New England Journal of Medicine, Nature Communications, Diabetes Care, and eClinicalMedicine, and Innovent notes it is the first innovative drug in China’s endocrinology and metabolism field with clinical results published in NEJM [1].
What should a US reader do instead?
Mazdutide is not an FDA-approved option, and the FDA has published a page flagging its concerns about unapproved GLP-1 drugs used for weight loss [9]. US readers weighing GLP-1 treatment can review the options that are approved in the US with a licensed clinician, and can read the FDA’s page on unapproved GLP-1 products before buying anything online [9].
Sources
- PR Newswire. Mazdutide 9 mg Achieves Up to 20.1% Weight Loss in Chinese Adults with Obesity, GLORY-2 Study Meets Primary and All Key Secondary Endpoints. November 19, 2025.
- PR Newswire. Innovent Announces Mazdutide Received Approval from China’s NMPA for Glycemic Control in Adults with Type 2 Diabetes. September 19, 2025.
- ClinicalTrials.gov. A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight (NCT06124807).
- ClinicalTrials.gov. A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight (NCT06143956).
- ClinicalTrials.gov. A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity (NCT06184568).
- ClinicalTrials.gov. A Study of IBI362 in Chinese Adolescents With Obesity or Overweight (NCT07255209).
- ClinicalTrials.gov. Clinical study record NCT06931028.
- ClinicalTrials.gov. A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder (NCT06817356).
- US Food and Drug Administration. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.
Frequently asked questions
Is mazdutide FDA approved?
No. Mazdutide is approved by China's NMPA for chronic weight management and for glycemic control in adults with type 2 diabetes, but no FDA approval, submission, or US marketing of the drug has been announced.
How much weight did people lose on mazdutide 9 mg?
In the Phase 3 GLORY-2 study, the mazdutide 9 mg group lost an average of 18.55% of body weight at 60 weeks versus 3.02% with placebo, and 44.0% lost at least 20%. In the subgroup without type 2 diabetes, the average was 20.08% and 48.7% lost at least 20%.
How is mazdutide different from semaglutide?
Mazdutide is a dual glucagon (GCG)/GLP-1 receptor agonist, a mammalian oxyntomodulin analog that Innovent says may also increase energy expenditure and improve hepatic fat metabolism through glucagon receptor activation.
Who makes mazdutide, and what is Eli Lilly's role?
Innovent Biologics of Suzhou, China develops and commercializes it in China, under an exclusive license from Eli Lilly for development and potential commercialization in China. Neither company has stated that Lilly holds rights elsewhere or plans any US filing.
Can mazdutide be imported or bought legally in the US?
No legal US pathway has been announced. Mazdutide has no FDA approval, and the FDA publishes a page titled "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss". Innovent itself states it does not recommend use of any unapproved drug or indication.
Are 'research use only' mazdutide vials safe?
There is no FDA-reviewed prescribing information for mazdutide, so no US label exists covering dosing, warnings, or interactions. The FDA has also published a page flagging its concerns about unapproved GLP-1 drugs used for weight loss.
What side effects were reported in the Chinese trials?
In GLORY-2, most gastrointestinal adverse events were mild to moderate and transient, 2.9% of the mazdutide group stopped treatment due to adverse events versus 0% on placebo, and no new safety signals were identified. The diabetes program reported a profile consistent with other GLP-1 receptor agonists.
Did mazdutide beat semaglutide head to head?
Head-to-head Phase 3 studies exist: DREAMS-3 versus semaglutide in type 2 diabetes with obesity met its primary endpoint, and GLORY-3 versus semaglutide 2.4 mg in obesity with fatty liver disease is ongoing. The announcements cited do not report the comparison numbers.
This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.