Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial
NCT07767552 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 249
Last updated 2026-08-17
Summary
The purpose of this study is to investigate and efficacy of Mastitide for diabetes remission in Chinese type 2 diabetic subjects with poor glycemic control on diet or exercise therapy alone or metformin/sodium-glucose cotransporter (SGLT2) inhibitor monotherapy.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Mazdutide
GLP-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist, administered by subcutaneous injection once weekly using a pre-filled pen device. Titration from 2 mg QW (weeks 0-4) to 4 mg QW (weeks 5-8) to 6 mg QW (weeks 9-24). Injection sites: abdomen, anterior-lateral thigh, or lateral upper arm, rotated at each injection.
- DRUG
-
Matching placebo for mazdutide, administered by subcutaneous injection once weekly using a pre-filled pen device identical in appearance, color, volume, and packaging to the active drug pen. Titration schedule mirrors the 6 mg mazdutide arm to maintain blinding.
Sponsors & Collaborators
-
Yanbing Li
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-08-30
- Completion
- 2029-06-30
Countries
- China
Study Locations
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