Mazdutide for Weight Management and Gout in Adults With Obesity

NCT07824895 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-K-062
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gout; Obesity (BMI>30); Metabolic Syndrome; Hyperuricemia

Keywords

GLP-1/GCGR dual agonist; Weight loss; Uric acid

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (10)

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

  Week 52；Unit：Percentage of Participants

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

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

• Time to First Gout Flare

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

• Change in Body Weight from Baseline to Week 52

  Baseline to Week 52；Unit：kg

• Percentage of Participants Achieving at Least 5% Weight Loss at Week 52

  Treatment period: Baseline to Week 52 Unit of Measure：Percentage of Participants

Other Outcomes (16)

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

  Week 52；Unit of Measure：Percentage of Participants

• Change from Baseline in Fasting Blood Glucose at Week 52

  Baseline to Week 52；Unit：mmol/L

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

  Baseline to Week 52；Unit：Percentage

Study Arms (1)

Mazdutide Treatment Group

EXPERIMENTAL

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.

Drug: Mazdutide

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.

Also known as: IBI362

Mazdutide Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosis of gout according to the 2015 ACR/EULAR classification criteria for gout, confirmed by the investigator; at least 2 gout flares in the past 6 months with supporting medical records/prescription documentation.
• Subjects must have been on a stable dose of urate-lowering therapy (ULT) for at least 8 weeks prior to enrollment: allowed agents include allopurinol, febuxostat, or other oral ULTs recognized by local guidelines; dose unchanged in the past 8 weeks; or discontinued ULT in the past 8 weeks; not taking colchicine for gout flare prophylaxis.
• Body weight change \< 5% in the past 6 months controlled by diet and exercise alone.
• HbA1c ≤ 10.0%; background antidiabetic medications allowed: metformin, stable-dose insulin, sulfonylureas (SUs), SGLT2 inhibitors; prohibited: GLP-1 receptor agonists, DPP-4 inhibitors; background medications must be stable for ≥ 8 weeks prior to enrollment.
• Subjects have received standardized gout management or healthy lifestyle education for ≥ 6 months prior to enrollment, including but not limited to urate-lowering therapy, dietary modification, alcohol control, weight management, and gout-related behavioral interventions. These management measures have been stable for at least 2 months prior to enrollment without significant off-protocol changes. Subjects agree to maintain their previous lifestyle and disease management habits during the study, without actively changing dietary patterns, alcohol intake, exercise intensity, or other factors that may affect gout flares, unless deemed medically necessary by the investigator.

You may not qualify if:

• \. 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.
• \. Average daily smoking ≥ 5 cigarettes in the 3 months prior to screening, or inability to stop using any tobacco products during the trial.
• \. History of specific allergies (asthma, urticaria, eczema, etc.), allergic constitution, or allergy to GLP-1/GCG dual receptor agonists and excipients. Subjects judged unsuitable for enrollment due to allergy to the study drug or its excipients. Subjects who participated in other clinical trial drug studies within 3 months prior to enrollment and are judged unsuitable by the investigator.
• \. History of heavy alcohol use and unwillingness to abstain from alcohol throughout the study period: \> 14 units of alcohol per week (1 unit ≈ 10 mL alcohol, approximately 285 mL beer at 3.5%, 25 mL spirits at 40%, or 100 mL wine at 10%).
• \. Body weight change \> 5.0% (self-reported) in the 12 weeks prior to screening controlled by diet and exercise alone.
• \. ULT dose adjustment within 8 weeks prior to screening, or expected need for ULT adjustment during the study. Acute gout flare within 2 weeks prior to enrollment. Inability to maintain stable ULT dose during the study.
• Medication History:
• 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.
• Use of any diuretics within 2 weeks prior to enrollment, or expected use during the study.
• Unstable dosing of medications for comorbid conditions within 4 weeks prior to enrollment, or expected adjustment of treatment regimen during the study.
• Use of any other prescription drugs, over-the-counter drugs, traditional Chinese medicine, or health supplements within 1 week prior to enrollment or within 5 drug half-lives (whichever is longer).
• Use of drugs or treatments that may cause significant weight gain or loss within 3 months:
• Corticosteroids (short-term use \< 7 days or topical, inhaled, intraocular, or intranasal administration excluded);

Sponsors & Collaborators

• Hongwei Jiang: lead
• Shanghai 10th People's Hospital: collaborator
• Second Affiliated Hospital, Zhejiang University, School of Medicine: collaborator

MeSH Terms

Conditions

Gout; Obesity; Hyperuricemia; Metabolic Syndrome; Weight Loss

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Body Weight Changes

Study Officials

• Hongwei Jiang, MD

  The First Affiliated Hospital of Henan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Puyu Li MD

CONTACT

8615837970639; lylpy1227@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 17, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to jianghw@haust.edu.cn. To gain access, data requestors will need to sign a data access agreement.