Mazdutide for Weight Management and Gout in Adults With Obesity

What Was Tested

In this phase 4 trial, researchers set out to test Mazdutide for gout.

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.

It had 1 arm (groups): Mazdutide Treatment Group (experimental).

The registry classes the interventions as drug.

More on the Plan

Study Background and Rationale Gout is the most common form of inflammatory arthritis, and its prevalence is rising in parallel with the global obesity epidemic.

Mazdutide is a novel, long-acting dual Glucagon-like Peptide-1 Receptor (GLP-1R) and Glucagon Receptor (GCGR) agonist.

Study Design and Objectives This is a single-arm, open-label, pre-post controlled exploratory clinical study.

The primary objective is to evaluate the effect of 52 weeks of Mazdutide treatment on the Annualized Flare Rate (AFR) in adults with obesity and gout, by comparing it to the AFR in the 12 months prior to treatment.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Aged 18 to 65 years (inclusive), male or female. Obesity: BMI ≥ 30.0 kg/m².

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: medication history:; use of any clinical trial drug within 3 months prior to enrollment; use of any diuretics within 2 weeks prior to enrollment, or expected use during the study.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Mazdutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-09-15 with completion listed for 2027-12-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Annualized Flare Rate (AFR) (time frame: Baseline to Week 52；Unit of Measure: Flares per person-year).

It also tracked 10 secondary outcomes, for example Change in Serum Uric Acid from Baseline at Weeks 24 and 52, Time to First Gout Flare, Change in Body Weight from Baseline to Week 52, Number of Episodes of Acute Anti-inflammatory Medication Use for Gout Flares, Change from Baseline in EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Index Score at Week 52 and Change from Baseline in Pain Intensity on the Numeric Rating Scale at Week 52.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Mazdutide in 30 people with gout.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, Gout research.