Mazdutide for Weight Management and Gout in Adults With Obesity

Sponsor
Hongwei Jiang
Study ID
NCT07824895
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    Mazdutide is a dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR). It is administered via subcutaneous injection once weekly. The dosing regimen involves a titration strategy starting at 2 mg/week for the first 4 weeks, potentially increasing to 4 mg, 6 mg, or 9 mg based on tolerability and efficacy.

Study Details

This is a single-arm, open-label, pre-post controlled study to evaluate the effect of Mazdutide on the annualized flare rate (AFR) in adults with obesity and gout. The study will enroll 30 subjects aged 18 to 65 years with a Body Mass Index (BMI) ≥ 30.0 kg/m². Eligible participants must have a confirmed diagnosis of gout and a history of at least 2 gout flares in the past 6 months. The primary objective is to compare the AFR during the 52-week treatment period with the 12 months prior to treatment. All subjects will receive Mazdutide with a dose-escalation regimen, and their outcomes will be compared to their own baseline data.

Key Dates

First listed
Sep 17, 2026
Start date
Sep 15, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mazdutide Treatment Group
    Participants in this arm will receive subcutaneous injections of Mazdutide once weekly for 52 weeks. The treatment starts with an initial dose of 2mg/week for 4 weeks. Based on tolerability, the dose may be titrated up to 4mg/week, 6mg/week, and potentially 9mg/week in subsequent 4-week intervals. Participants will continue their stable urate-lowering therapy throughout the study.

Primary Outcome Measure

Annualized Flare Rate (AFR) [ Time Frame: Baseline to Week 52；Unit of Measure: Flares per person-year ]

Central Contacts

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