Drugs / Mazdutide
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Mazdutide

English name mazdutide
also known as IBI362 · LY3305677 · Mazdutida

Protein / enzyme biologic targets GCGR via activation

Developed for
obesity disorder · type 2 diabetes mellitus · metabolic dysfunction-associated steatohepatitis · alcohol-related disorders · cirrhosis of liver · cognitive impairment with or without cerebellar ataxia · coronary atherosclerosis · dementia
+12 more · diastolic heart failure · gout · hypertensive disorder · metabolic dysfunction-associated steatotic liver disease · mild heart failure · morbid obesity · NAFLD1 · obstructive sleep apnea syndrome · pancreas disorder · polycystic ovary syndrome · portal hypertension · prediabetes syndrome
Investigated by
Innovent Biologics (Suzhou) Co. Ltd. · Eli Lilly and Company · Beijing Friendship Hospital · Shanghai Zhongshan Hospital · Anhui Provincial Hospital · Changzhou No.2 People's Hospital
+23 more · China National Center for Cardiovascular Diseases · China-Japan Friendship Hospital · First Affiliated Hospital of Chongqing Medical University · Hongwei Jiang · Huadong Hospital · Innovent Biologics, Inc. · Jiangsu Province Hospital of Traditional Chinese Medicine · Nanjing First Hospital, Nanjing Medical University · Second Affiliated Hospital, Zhejiang University, School of Medicine · Shandong Provincial Hospital · Shanghai 10th People's Hospital · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The Second Affiliated Hospital of Chongqing Medical University · The Second Affiliated Hospital of Dalian Medical University · Tianjin Fifth Central Hospital · Tianjin First Central Hospital · Tianjin Medical University · Tianjin TEDA Hospital · Tianjin Third Central Hospital · Tongji Hospital · West China Hospital · Xiangya Hospital of Central South University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed China (NMPA) — obesity disorder —

“NDA for mazdutide 9 mg for weight management in adults was formally submitted in November 2025 and accepted by the National Medical Products Administration (NMPA).” innoventbio.com ↗

“the marketing application for mazdutide 9 mg for long-term weight management in adults with moderate-to-severe obesity was accepted for review” innoventbio.com ↗

Trials 39

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT06536023 Aug 2024 → Jul 2025 — Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 1 NCT05793450 May → Sep 2023 impaired renal function disease Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 1 NCT05815680 Apr → Aug 2023 obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 1 NCT05623839 Nov 2022 → Jun 2023 obesity disorder Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT04773977 Mar 2021 obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 1 NCT03928379 Oct 2019 → Jul 2021 type 2 diabetes mellitus Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT03325387 Oct 2017 → Aug 2018 — Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT02972645 Dec 2016 → Jul 2017 — Eli Lilly and Company Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07000955 Jun 2025 → Sep 2026 overdue obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Active not recruiting No outcome recorded
Phase 1/2 NCT06519656 Oct 2024 → Sep 2026 polycystic ovary syndrome Shanghai Zhongshan Hospital Completed No outcome recorded
Phase 1/2 NCT04466904 Sep 2020 → May 2021 type 2 diabetes mellitus Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 1/2 NCT04440345 Jun 2020 → Jun 2021 obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 27 trials · 2 met primary
Phase 2 NCT06937749 Jul 2025 → Apr 2026 overdue metabolic dysfunction-associated steatohepatitis Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded
Phase 2 NCT06862908 Mar 2025 → Sep 2026 overdue diastolic heart failure, mild heart failure, obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Active not recruiting No outcome recorded
Phase 2 NCT06817356 Feb 2025 → Mar 2026 alcohol-related disorders Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT06124807 Nov 2023 → Jan 2025 obesity disorder Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT06143956 Nov 2023 → Sep 2027 expected obesity disorder Eli Lilly and Company Recruiting No outcome recorded
Phase 2 NCT04965506 Sep 2021 → Apr 2022 type 2 diabetes mellitus Innovent Biologics (Suzhou) Co. Ltd. Completed Met primary
Phase 2 NCT04904913 Jun 2021 → Mar 2023 obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Completed Met primary
Phase 310 trials · 5 met primary
Phase 3 NCT07469800 Apr → Aug 2026 overdue hypertensive disorder, obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded
Phase 3 NCT07255209 Dec 2025 → Oct 2027 expected — Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded
Phase 3 NCT07083154 Sep 2025 → Aug 2029 expected cognitive impairment with or without cerebellar ataxia, dementia, type 2 diabetes mellitus The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting No outcome recorded
Phase 3 NCT06931028 Jun 2025 → May 2027 expected obesity disorder, obstructive sleep apnea syndrome Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded
Phase 3 NCT06884293 May 2025 → Dec 2026 expected metabolic dysfunction-associated steatotic liver disease, obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Active not recruiting No outcome recorded
Phase 3 NCT06184568 Feb 2024 → Sep 2025 obesity disorder, type 2 diabetes mellitus Innovent Biologics (Suzhou) Co. Ltd. Completed Met primary
Phase 3 NCT06164873 Dec 2023 → Jun 2025 overdue obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Active not recruiting Met primary
Phase 3 NCT05606913 Jan 2023 → Jan 2024 type 2 diabetes mellitus Innovent Biologics (Suzhou) Co. Ltd. Completed Met primary
Phase 3 NCT05628311 Jan → Oct 2023 type 2 diabetes mellitus Innovent Biologics (Suzhou) Co. Ltd. Completed Met primary
Phase 3 NCT05607680 Nov 2022 → Aug 2023 obesity disorder Innovent Biologics (Suzhou) Co. Ltd. Completed Met primary
Phase 44 trials
Phase 4 NCT07824895 Sep 2026 → Dec 2027 expected gout, metabolic syndrome X, obesity disorder Hongwei Jiang Not yet recruiting No outcome recorded
Phase 4 NCT07718126 Sep 2026 → Feb 2029 expected metabolic dysfunction-associated steatohepatitis West China Hospital Recruiting No outcome recorded
Phase 4 NCT07654062 Jul 2026 → Jun 2028 expected prediabetes syndrome Shandong Provincial Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07657676 May 2026 → Oct 2027 expected coronary atherosclerosis, obesity disorder China National Center for Cardiovascular Diseases Not yet recruiting No outcome recorded
Phase not applicable6 trials
— NCT07803705 Nov 2026 → Jun 2028 expected obesity disorder, pancreas disorder Tongji Hospital Not yet recruiting No outcome recorded
— NCT07713992 Sep 2026 → Dec 2027 expected NAFLD1, type 2 diabetes mellitus Tianjin Medical University Not yet recruiting No outcome recorded
— NCT07797101 Sep 2026 → May 2029 expected cirrhosis of liver, fatty liver disease, portal hypertension The Second Affiliated Hospital of Chongqing Medical University Not yet recruiting No outcome recorded
— NCT07517042 Jun 2026 → Dec 2028 expected obesity disorder Shanghai Zhongshan Hospital Recruiting No outcome recorded
— NCT07633639 May 2026 → May 2028 expected obesity disorder China-Japan Friendship Hospital Recruiting No outcome recorded
— NCT07135141 Sep 2025 → Sep 2027 expected morbid obesity Beijing Friendship Hospital Not yet recruiting No outcome recorded
Comparator or background therapy2 trials
Phase 2 NCT07843862 Comparator Oct 2026 → Apr 2027 expected type 2 diabetes mellitus Fujian Shengdi Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07417306 Comparator Mar 2026 → Aug 2027 expected type 2 diabetes mellitus Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 37

DateIssuerRelease
2026-06-08 Innovent Biologics (Suzhou) Co. Ltd. Results 2026ADA | Innovent Biologics Presents Results of DREAMS-3: the First Globally Approved GCG/GLP-1 Dual Receptor Agonist versus Semaglutide in a Head-to-Head Phase 3 Randomized Controlled Trial innoventbio.com ↗
Mazdutide 6 mg demonstrated superior efficacy in both glycemic control and weight reduction.
2026-06-08 Innovent Biologics (Suzhou) Co. Ltd. Results The Phase 3 GLORY-2 study of mazdutide 9 mg in Chinese adults with moderate to severe obesity was simultaneously published in JAMA and presented at the ADA Scientific Sessions innoventbio.com ↗
2026-06-06 Innovent Biologics (Suzhou) Co. Ltd. Results Innovent Announces Phase 1b Clinical Study Results of Mazdutide in Chinese Adolescents with Obesity Presented as an Oral Report at the American Diabetes Association (ADA) Scientific Sessions innoventbio.com ↗
Results showed that mazdutide 4 mg and 6 mg demonstrated a manageable safety and tolerability profile in Chinese adolescents with obesity.
2026-05-08 Innovent Biologics (Suzhou) Co. Ltd. Regulatory Mazdutide pre-filled multi-dose pen approved by NMPA, bringing new options for long-term treatment of patients with type 2 diabetes innoventbio.com ↗
2026-03-30 Innovent Biologics (Suzhou) Co. Ltd. Results A weight loss of over 15 kg in one year achieved with 9 mg mazdutide in a Phase 2 study of Chinese adults with a BMI ≥ 30 kg/m2; results published in MED, a Cell Press Journal innoventbio.com ↗
2025-12-18 Innovent Biologics (Suzhou) Co. Ltd. Results Nature | Two Phase 3 Clinical Results of Mazdutide (GLP-1/GCG Dual Receptor Agonist) in Chinese Adults with Type 2 Diabetes Have Been Back-to-Back Published in Nature innoventbio.com ↗
The two Phase 3 studies published in Nature respectively demonstrated the efficacy and safety of mazdutide monotherapy (DREAMS-1, NCT05628311) and add-on therapy to oral anti-diabetic drugs (DREAMS-2, NCT05606913) in Chinese adult participants with T2D.
2025-12-15 Innovent Biologics (Suzhou) Co. Ltd. Regulatory Innovent Announces Approval of Mazdutide Injection in Macao, Introducing a Novel Therapeutic Option to Patients with Obesity and Overweight innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that mazdutide (glucagon [GCG]/glucagon-like peptide-1 [GLP-1] dual receptor agonist) has been approved for marketing by the Pharmaceutical Administration Bureau (ISAF) of the Macao Special Administrative Region of China.
2025-12-12 Innovent Biologics (Suzhou) Co. Ltd. Results Mazdutide Demonstrates Significant Weight Loss and Metabolic Benefits in Phase 1b Clinical Trial in Chinese Adolescents with Obesity innoventbio.com ↗
After 12 weeks of treatment, the 4 mg and 6 mg mazdutide groups achieved reductions in BMI from baseline of 8.78% and 10.99%, respectively, with corresponding body weight reductions of 7.72 kg and 8.65 kg.
2025-11-25 Innovent Biologics (Suzhou) Co. Ltd. Regulatory Mazdutide 9mg Supplementary Application Accepted for Review by China's NMPA, Potentially Offering a Novel Drug Option for Moderate-to-Severe Obese Population innoventbio.com ↗
the supplementary application for the 9 mg dosage of mazdutide, an innovative glucagon (GCG)/ glucagon-like peptide-1 (GLP-1) dual receptor agonist, for the long-term weight management in adults with moderate to severe obesity has been accepted for review
2025-11-20 Innovent Biologics (Suzhou) Co. Ltd. Results 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 innoventbio.com ↗
At Week 60, the mazdutide 9 mg group achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group.
2025-10-28 Innovent Biologics (Suzhou) Co. Ltd. Results Innovent’s Mazdutide Shows Superiority in Glycemic Control with Weight Loss over Semaglutide in a Head-to-head Phase 3 Clinical Trial DREAMS-3 innoventbio.com ↗
The proportion of participants achieving HbA1c < 7.0% and a ≥10% reduction in body weight from baseline was 48.0% in the mazdutide group and 21.0% in the semaglutide group
2025-09-19 Innovent Biologics (Suzhou) Co. Ltd. Regulatory Innovent Announces Mazdutide Received Approval from China's NMPA for Glycemic Control in Adults with Type 2 Diabetes innoventbio.com ↗
Mazdutide is the world's first dual GCG/GLP-1 receptor agonist approved for glycemic control in adults with T2D.

All press releases naming this drug 51 releases

DateIssuerRelease

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 43 sources stand behind the page.

FieldValueCited text
Known as Mazdutide “Mazdutide (also known as IBI362 or LY3305677), a novel once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist” PMID 36247927 ↗ Oct 2022
16

NCT07083154 ↗

NCT07657676 ↗

NCT06124807 ↗

NCT07718126 ↗

NCT07824895 ↗

NCT07713992 ↗

NCT07135141 ↗

NCT07633639 ↗

NCT07417306 ↗

NCT07843862 ↗

Show 6 more sources

Known as IBI362 “Mazdutide (also known as IBI362 or LY3305677), a novel once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist” PMID 36247927 ↗ Oct 2022
20

“Mazdutide (IBI362) is a GLP-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist.” NCT07654062 ↗

NCT06184568 ↗

NCT07000955 ↗

NCT06536023 ↗

NCT04904913 ↗

NCT04773977 ↗

NCT06164873 ↗

NCT06862908 ↗

NCT07255209 ↗

NCT05793450 ↗

Show 10 more sources

Known as LY3305677 “We conducted a randomised, placebo-controlled phase 1b study (ClinicalTrials.gov: NCT04466904) to evaluate the safety and efficacy of IBI362 (LY3305677), a GLP-1 and glucagon...” PMID 35750681 ↗ Jun 2022
6

“Mazdutide (also known as IBI362 or LY3305677), a novel once-weekly glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist” PMID 36247927 ↗ Oct 2022

NCT02972645 ↗

NCT03325387 ↗

NCT06143956 ↗

NCT05623839 ↗

NCT03928379 ↗

Known as Mazdutida ChEMBL registry synonym — accepted as the source's own label CHEMBL5095358 ↗
Action Activate “glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist” PMID 36247927 ↗ Oct 2022
Modality Protein / enzyme biologic — CHEMBL5095358 ↗
Route Subcutaneous “Single escalating doses of LY3305677 administered subcutaneously (SC)” NCT02972645 ↗
Target GCGR “GLP-1R and GCGR dual agonist” NCT06519656 ↗