At a glance
- Mazdutide is a peptide that stimulates the GLP-1 and glucagon receptors together, administered subcutaneously once a week. [1]
- It received its first approval in China in June 2025 for weight management; a type 2 diabetes indication was added in September 2025. [9] [8]
- It has no FDA approval in the US, no EMA registration in the EU, and is not licensed in Türkiye. [10] [11] [12]
- The phase 3 studies were conducted in Chinese adults and funded by the manufacturer; the most common adverse events are gastrointestinal. [1] [2]
- This guide gives no information on dose, method of use or product source; it reports study findings and regulatory status.
What is mazdutide?
Mazdutide is a synthetic peptide that acts on glucagon-like peptide-1 (GLP-1) and glucagon receptors together, administered subcutaneously once a week. [1] Chemically, it is a mammalian oxyntomodulin analog with a fatty acid side chain attached. The authors of the Chinese phase 2 study base the rationale for developing molecules that also target the glucagon receptor on the energy-expenditure-increasing effect of glucagon. [5] In this respect it belongs to the same family as semaglutide and liraglutide, which act only on the GLP-1 receptor, tirzepatide, which acts on the GIP and GLP-1 receptors, and the investigational drug retatrutide, which acts on all three receptors, but with a different combination. The general features of the class: GLP-1 agonists.
During development, the molecule was also referred to by the codes IBI362 and LY3305677. [5] According to a review after the approval in China, mazdutide is also being clinically investigated for fatty liver, obstructive sleep apnea and alcohol use disorder. [8]
Is mazdutide approved? What is its status in Türkiye?
China: In its announcement dated June 27, 2025, China’s National Medical Products Administration (NMPA) stated that it had licensed mazdutide injection solution as a “Class 1 innovative drug.” The approved indication is long-term weight control, together with diet control and increased physical activity, in adults with a baseline body mass index (BMI) of 28 kg/m² or above (obesity, in the NMPA text) or a BMI of 24 kg/m² or above (overweight) who have at least one weight-related condition such as high blood sugar, high blood pressure, dyslipidemia, fatty liver or obstructive sleep apnea. [9] In September 2025, approval was also given in China for blood sugar control in adults with type 2 diabetes. [8]
United States: The FDA page on unapproved GLP-1 drugs (content updated October 1, 2026) states that it has warned companies that illegally sell unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide by falsely labeling them “for research purposes” or “not for human use.” According to the FDA, these products were sold directly to consumers for human use together with dosing instructions; the agency asks consumers not to buy these products, whose quality is unknown and which may be harmful to health. [10]
European Union: In the version of the EMA’s human medicines dataset time-stamped October 18, 2026, there is no medicine record containing mazdutide. [11]
Türkiye: The Licensed Human Medicinal Products List of TİTCK (Turkish Medicines and Medical Devices Agency) dated October 16, 2026 contains no product with mazdutide. [12] Two provisions in the legislation are directly relevant:
- Article 3 of Law No. 1262 on Pharmaceutical and Medicinal Preparations (İspençiyari ve Tıbbi Müstahzarlar Kanunu) requires Ministry permission before domestically produced medicinal preparations are placed on the market and before those produced abroad are imported. [13]
- Article 24 of Law No. 6197 on Pharmacists and Pharmacies (Eczacılar ve Eczaneler Hakkında Kanun) provides that medicines cannot be sold on the internet or in any other electronic medium. [14]
Being approved in another country does not mean a drug is licensed in Türkiye; the approval in China does not change this.
What did the obesity studies find?
The weight percentages in the table are mean changes from baseline. Dose groups are named “low, high.”
| Study | Population studied | Main result |
|---|---|---|
| Phase 2, China (Nat Commun, 2023; 24 weeks, interim analysis) | 248 Chinese adults with BMI ≥24 and a comorbid condition, or BMI ≥28 | Weight change from −6.7% to −11.3% depending on dose; placebo +1.0% [5] |
| GLORY-1 (NEJM, 2025; 48 weeks) | 610 Chinese adults aged 18–75 with BMI ≥28, or 24–28 with a weight-related disease | Week 32 (primary endpoint): −10.09% / −12.55%; placebo +0.45%. Week 48: −11.00% / −14.01%; placebo +0.30% [1] |
| GLORY-2 (JAMA, 2026; 60 weeks) | 461 Chinese adults with BMI ≥30 (16.1% with type 2 diabetes; mean age 33.9) | −16.65%; placebo −1.50% (difference −15.15%; 95% CI −17.22 to −13.09) [2] |
| Phase 2, US (Lancet Diabetes Endocrinol, 2026; 48 weeks) | 179 adults with obesity or overweight without type 2 diabetes | Week 32: from −7.3% to −18.1% depending on dose; placebo −0.9% [6] |
In GLORY-1, the proportion of participants losing at least 15% at week 48 was 35.7% with the low dose, 49.5% with the high dose and 2.0% with placebo; changes in favor of mazdutide were reported in all prespecified cardiometabolic measurements. The primary analysis was done with a “treatment policy” approach that keeps in their own group those who stopped treatment early and those who started a new obesity treatment. [1] In GLORY-2, the proportion with at least 5% weight loss at week 60 was 84.3% versus 33.1%; efficacy and safety analyses were done in participants who received at least one dose. [2]
Three limits matter when reading. First, both phase 3 studies were conducted in China and in Chinese adults. [1] [2] Second, the only published efficacy data outside China are from the 179-person US phase 2 study; the primary endpoint was evaluated with an “efficacy” approach based on the assumption of continued treatment, and doses higher than in the Chinese studies were also tested in this study. [6] Third, the endpoints of these studies are weight and risk markers; they were not designed to measure events such as heart attack, stroke or death.
Funding: GLORY-1 was funded by the manufacturer, and company employees were among the authors. [1] In GLORY-2, six authors are company employees. [2] The US phase 2 study was funded by the co-developer company; most of the authors are employees and shareholders of this company. [6]
What did the type 2 diabetes studies find?
- DREAMS-1 (Nature, 2026): 320 Chinese people with type 2 diabetes not controlled with diet and exercise alone (mean HbA1c 8.24%, diabetes duration 1.9 years) were followed for 24 weeks placebo-controlled, followed by a 24-week extension period. At week 24, HbA1c fell by 1.57 points with the low dose, 2.15 points with the high dose and 0.14 points with placebo (difference versus placebo 1.43 and 2.02 points). Weight change was −5.61% and −7.81%, and −1.26% with placebo. The most common adverse events were diarrhea, decreased appetite and nausea. [3]
- DREAMS-2 (Nature, 2026): 731 Chinese people with type 2 diabetes using oral diabetes drugs were randomized to mazdutide or weekly dulaglutide for 28 weeks. Both doses met both the non-inferiority and superiority criteria versus dulaglutide in HbA1c: difference −0.24 points (P=0.0032) and −0.30 points (P=0.0003). The weight difference versus dulaglutide was −3.78% and −5.76%. Gastrointestinal adverse events were more frequent with mazdutide than with dulaglutide. [4]
In both studies, the authors include employees of the manufacturer and researchers who consult for the company. [3] [4] Mazdutide lowering HbA1c is a blood marker; reduction of diabetes complications (eye, kidney, cardiovascular events) was not measured in these studies.
Has it been compared with semaglutide or tirzepatide?
In the published phase 3 results, the comparison groups are placebo and dulaglutide. [1] [4] The design and baseline data paper of DREAMS-3, the study directly comparing it with semaglutide, has been published: 349 Chinese adults with obesity (BMI ≥28) and type 2 diabetes were randomized open-label to mazdutide or weekly semaglutide; the primary endpoint is achieving both HbA1c below 7% and at least 10% weight loss together at week 32. The paper states that the study was expected to be completed in early 2026. [7] The results of a study directly comparing it with tirzepatide had not been published in a peer-reviewed journal as of October 2026. Placing the averages of different studies side by side is not a reliable comparison, because participant characteristics and duration differ.
Why is the glucagon effect monitored separately?
Because of glucagon’s heart-stimulating effect, the heart rate increase in GLP-1 and glucagon dual agonists is expected to be more pronounced than with GLP-1 agonists alone. The authors of the Chinese phase 2 obesity study emphasize this point. [5] In the same study, the mean heart rate increase at week 24 was 5.38–8.75 beats per minute in the mazdutide groups and 4.81 beats with placebo; the increase returned to normal in the post-treatment follow-up period. Clinically relevant cardiac disorders were reported in 15 participants (8.1%) with mazdutide and 9 participants (14.5%) with placebo; all were mild, asymptomatic and transient findings detected on ECG. The most common sinus tachycardia rate was 2.8% with mazdutide and 3.2% with placebo. [5] This study did not enroll people with a history of heart attack, heart failure or cardiomyopathy, people with a heart rate below 50 or above 100 beats per minute at screening, or people with significant cardiac problems such as second- or third-degree heart block; the findings therefore cannot be generalized to these groups. [5]
What are the side effects of mazdutide?
- Gastrointestinal complaints: They are the most common adverse events in all studies and are mostly mild to moderate in severity. [1] In GLORY-2, vomiting was reported in 53.1% in the mazdutide group versus 1.3% with placebo; nausea 46.9% versus 3.2%; diarrhea 39.4% versus 6.5%. [2]
- Discontinuation: Discontinuation due to adverse events was 1.5% with the low dose, 0.5% with the high dose and 1.0% with placebo in GLORY-1 [1]; 2.9% versus 0% in GLORY-2. [2] In the US phase 2 study, this rate rose to 20% in the highest dose arm and was mostly due to gastrointestinal disorders. [6]
- Low blood sugar: In DREAMS-1, the most common adverse events were diarrhea, decreased appetite and nausea; the published summary gives no hypoglycemia rate. [3]
- Heart rate: Summarized in the section above. [5]
GLP-1 class warnings such as thyroid C-cell tumor, pancreatitis, gallbladder disease and aspiration under anesthesia appear on the labels of licensed drugs; there is no product information approved by a regulator outside China for mazdutide. For class warnings: GLP-1 agonists.
Why is mazdutide sold online risky?
The FDA states that it has warned companies selling unapproved GLP-1 products, including mazdutide, to consumers with dosing instructions under a “for research purposes” label, that the quality of these products is unknown, and that they may be harmful to health. [10] In Türkiye, the import and marketing of an unlicensed drug depend on Ministry permission; selling medicines online is prohibited by law. [13] [14] The safety findings in the studies were obtained in adults selected by entry criteria, with a product of known content, and under physician monitoring; they cannot be transferred to a product whose content and sterility are unknown. [2]
Evidence table: claim, population and limits
| Claim | Population studied | Limit |
|---|---|---|
| Produces weight loss | 610 and 461 Chinese adults (two phase 3); 179 US adults (phase 2) | Phase 3 data from a single country; manufacturer-funded. [1] [2] [6] |
| Lowers HbA1c in type 2 diabetes | 320 and 731 Chinese people with type 2 diabetes | Results at 24–28 weeks; complications not measured. [3] [4] |
| More effective than other GLP-1 drugs | Single phase 3 with dulaglutide (731 people) | The semaglutide comparison was published at the design stage; no comparison with tirzepatide. [4] [7] |
| Protects the heart | — | No cardiovascular outcomes study; heart rate rose in phase 2. [5] |
| “For research purposes” products are the same drug | — | According to the FDA, they are unapproved products of unknown quality. [10] |
Limits of this guide
This page summarizes the published peer-reviewed studies on mazdutide and the statements of regulatory bodies. It contains no dose, administration, storage or sourcing information and recommends use under no circumstances. Dose groups in the studies are referred to only as low and high. For most of the phase 3 papers, only published abstracts were used; the subgroup and safety tables in the full texts may contain more detailed information than the summary numbers on this page. The decision on treating obesity and type 2 diabetes in adults is made through individual clinical evaluation among licensed options.
What does the evidence say?
What it does and does not affectSupported by evidence
- BWeight loss in obesity and overweight — Chinese adultsTwo phase 3 RCTs: GLORY-1 (610 people) −11.0% and −14.0% at week 48, placebo +0.3%; GLORY-2 (461 with obesity) −16.65% at week 60, placebo −1.50%. Manufacturer-funded; single country.
- BBlood sugar (HbA1c) in type 2 diabetes — Chinese adultsTwo phase 3 RCTs: DREAMS-1 (320 people) HbA1c −1.57 and −2.15 points at week 24, placebo −0.14; DREAMS-2 (731 people) superior to dulaglutide. Manufacturer-funded.
Limited or insufficient evidence
- CHbA1c and weight versus dulaglutide — single phase 3DREAMS-2 (731 people, 28 weeks): HbA1c difference −0.24 and −0.30 points, weight difference −3.78% and −5.76%. Gastrointestinal adverse events more frequent with mazdutide.
- CWeight loss outside China (US) — phase 2Single phase 2 RCT (179 people, US): weight change at week 32 from −7.3% to −18.1% depending on dose, placebo −0.9%. At the highest dose, discontinuation due to adverse events 20%.
What do the A–E grades mean?
The letter describes the strength of evidence for a specific claim, not the size of the benefit or a usage recommendation. E does not mean ineffectiveness has been proven.
- AStrong
- Established physiology (e.g. correcting a deficiency) or strong, consistent, direct human studies
- BModerate
- Supportive human evidence; small effect or some limitations
- CLimited
- A single randomised trial, mixed results or low-certainty human findings
- DInsufficient
- Small, uncontrolled or indirect evidence; not enough to judge
- ENo benefit shown / not studied in humans
- No benefit shown for the claim, or only animal or cell data exist
These grades are Half-Life Journal’s editorial evidence summary; they are not a formal GRADE rating or independent medical approval.
The letter shows evidence strength; it is not a score for positive effect or a usage recommendation.
Frequently asked questions
Is mazdutide an approved drug?
It is approved only in China: the NMPA granted approval for long-term weight management in June 2025 and for blood sugar control in type 2 diabetes in September 2025. It has no FDA approval in the US, no EMA registration in the EU, and is not licensed in Türkiye.
How much weight was lost with mazdutide?
In GLORY-1, with 610 Chinese adults, the mean weight change at week 48 was −11.0% with the low dose, −14.0% with the high dose and +0.3% with placebo. In GLORY-2, in 461 Chinese adults with obesity, weight change at week 60 was −16.65% with mazdutide and −1.50% with placebo.
What is the difference between mazdutide and semaglutide or tirzepatide?
Mazdutide stimulates the glucagon receptor along with the GLP-1 receptor; semaglutide acts only on the GLP-1 receptor, and tirzepatide on the GIP and GLP-1 receptors. In published phase 3 studies, mazdutide was compared only with placebo and dulaglutide; the design paper of the comparison study with semaglutide (DREAMS-3) has been published.
Is mazdutide sold in Türkiye?
No. Mazdutide is not on the Licensed Human Medicinal Products List of TİTCK (Turkish Medicines and Medical Devices Agency) dated October 16, 2026. Law No. 1262 requires Ministry permission before medicines are placed on the market or imported; Law No. 6197 prohibits the online sale of medicines.
Is mazdutide sold online as “for research purposes” safe?
The FDA states that it has warned companies selling unapproved products containing mazdutide to consumers with “for research purposes” or “not for human use” labels. According to the FDA, the quality of these products is unknown and they may be harmful to health.
Sources
- RCT Ji L et al. — Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight (GLORY-1; N Engl J Med) (2025)Back to text ↑
- RCT 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)Back to text ↑
- RCT Zhu D et al. — Mazdutide versus placebo in Chinese adults with type 2 diabetes (DREAMS-1; Nature) (2026)Back to text ↑
- RCT Guo L et al. — Mazdutide versus dulaglutide in Chinese adults with type 2 diabetes (DREAMS-2; Nature) (2026)Back to text ↑
- RCT Ji L et al. — A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity (Nat Commun) (2023)Back to text ↑
- RCT Hsia SH et al. — Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial (Lancet Diabetes Endocrinol) (2026)Back to text ↑
- Source Luo Y et al. — Mazdutide versus Semaglutide for the treatment of type 2 diabetes and obesity: Rationale, design and baseline data of DREAMS-3 phase 3 trial (Contemp Clin Trials) (2026)Back to text ↑
- Guideline / review Shirley M — Mazdutide: First Approval (Drugs) (2025)Back to text ↑
- Institution Çin Ulusal Tıbbi Ürünler İdaresi (NMPA) — 国家药监局批准玛仕度肽注射液上市 (mazdutid enjeksiyonluk çözeltinin ruhsatlandırılması, 27.06.2025) (2025)Back to text ↑
- Institution FDA — FDA's concerns with unapproved GLP-1 drugs used for weight loss (içerik güncelliği 01.10.2026) (2026)Back to text ↑
- Institution EMA — Medicines for human use, veri seti (JSON; 18.10.2026 zaman damgalı sürüm) (2026)Back to text ↑
- Institution TİTCK — Ruhsatlı Beşeri Tıbbi Ürünler Listesi (16.10.2026) (2026)Back to text ↑
- Institution 1262 sayılı İspençiyari ve Tıbbi Müstahzarlar Kanunu (madde 3)Back to text ↑
- Institution 6197 sayılı Eczacılar ve Eczaneler Hakkında Kanun (madde 24; 6514 sayılı Kanunla değişik)Back to text ↑
Method: Institutional clinical guidance and relevant studies were compared. Each finding is presented with its population, outcome, sources and limitations. Independent medical review has not yet been completed.
Updated
This content is for information only and is not medical advice. It does not recommend doses, products or vendors. Talk to your clinician before making any health decision.


