Mazdutide for Weight Management and Gout in Adults With Obesity

ConditionsGout Obesity (BMI>30)Hyperuricemia Metabolic Syndrome

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorHongwei Jiang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent is obtained before trial entry, and the subject fully understands the trial content, procedures, and potential adverse reactions; able to complete the study according to the protocol requirements.

Subjects (including male subjects) have no plans for pregnancy, sperm donation, or egg donation from 14 days before screening until 3 months after trial completion, and voluntarily agree to use effective contraception.

Aged 18 to 65 years (inclusive), male or female.

Obesity: BMI ≥ 30.0 kg/m².

Disqualifiers

1. Persistent or significant lifestyle changes in the 6 months prior to enrollment, including substantial adjustment in alcohol consumption, extreme dietary pattern changes, initiation or discontinuation of systemic urate-lowering therapy, initiation or discontinuation of diuretics/uricosuric agents, etc. If the investigator determines that such changes may have a clinically meaningful impact on gout flares or uric acid levels, the subject will be excluded.

Use of any clinical trial drug within 3 months prior to enrollment.

Use of other urate-lowering or uric acid-affecting drugs (e.g., lesinurad) within 2 weeks prior to randomization, or inability to discontinue other urate-lowering or uric acid-affecting drugs during the study.

Use of aspirin > 325 mg daily within 2 weeks prior to enrollment, or unstable aspirin dosing, or expected use during the study.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Mazdutide Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Annualized Flare Rate (AFR)

The annualized gout flare rate (AFR) will be calculated as the total number of confirmed gout flares occurring during the 52-week treatment period divided by the participant's time at risk during the treatment period, expressed as flares per person-year. Confirmed gout flares will be identified using predefined clinical criteria adapted from published gout flare definitions. The AFR during the 52-week treatment period will be compared with the participant's annualized gout flare rate during the 12 months prior to baseline.

Time frame

Baseline to Week 52；Unit of Measure: Flares per person-year

Secondary outcomes

Percentage of Participants Achieving Serum Uric Acid <6 mg/dL at Week 52

The percentage of participants achieving a serum uric acid level \<6 mg/dL (\<360 µmol/L) at Week 52.

Time frame

Week 52；Unit：Percentage of Participants

Change in Serum Uric Acid from Baseline at Weeks 24 and 52

Change from baseline in serum uric acid (SUA) levels at Weeks 24 and 52.

Time frame

Baseline to Weeks 24 and 52；Unit：mg/dL

Time to First Gout Flare

The time from initiation of study treatment to the first confirmed gout flare during the 52-week treatment period. Participants without a confirmed gout flare will be censored at Week 52 or at the time of their last assessment during the treatment period, whichever occurs first.

Time frame

Treatment period: Baseline to Week 52 Unit of Measure：Days

Change in Body Weight from Baseline to Week 52

The change in body weight (kg) from baseline to Week 52.

Time frame

Baseline to Week 52；Unit：kg

Other outcomes

Percentage of Participants Achieving Serum Uric Acid <5 mg/dL at Week 52

The percentage of participants achieving a serum uric acid level \<5 mg/dL (\<300 µmol/L) at Week 52.

Time frame

Week 52；Unit of Measure：Percentage of Participants

Change from Baseline in Fasting Blood Glucose at Week 52

Change from baseline in fasting blood glucose at Week 52.

Time frame

Baseline to Week 52；Unit：mmol/L

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52

Change from baseline in hemoglobin A1c (HbA1c) at Week 52.

Time frame

Baseline to Week 52；Unit：Percentage

Change from Baseline in Total Cholesterol at Week 52

Change from baseline in total cholesterol level at Week 52.

Time frame

Baseline to Week 52；Unit：mmol/L

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hongwei Jiang

Lead sponsor

Henan University of Science and Technology

Sponsor institution

Shanghai 10th People's Hospital

Collaborator

Second Affiliated Hospital, Zhejiang University, School of Medicine

Collaborator

Source ClinicalTrials.gov

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