Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial

Sponsor
Yanbing Li
Study ID
NCT07767552
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    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.
  • Placebo — 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.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Aug 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
249 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mazdutide 6 mg
    ①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks； ③6mg, SC, once a week\* 40weeks.
  • Placebo Comparator: placebo
    placebo, SC, once a week\* 32weeks;

Primary Outcome Measure

Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44 [ Time Frame: Baseline, 44 weeks ]

Central Contacts

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