Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

What Was Tested

In this not phased trial, researchers set out to test Mazdutide.

It had two arms (groups): Sleeve gastrectomy plus mazdutide group (experimental) and Sleeve gastrectomy plus mazdutide placebo group (placebo comparator).

Participants will receive weekly subcutaneous injections of matched placebo at 5th month post sleeve gastrectomy.

The registry classes the interventions as drug.

Who Took Part

The registry lists 256 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Aged 18-70 years (inclusive), male or female;. BMI≥37.5 kg/m2, with or without obesity-related complications;. Planned to take sleeve gastrectomy. Understand the trial protocol, voluntarily sign the informed consent form (ICF), and agree to follow all study requirements and restrictions.

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: previous gastrointestinal surgery such as stomach and duodenum, or weight loss and metabolic surgery;; history of thyroid c-cell carcinoma, multiple endocrine neoplasia (men) 2a or 2b, or relevant family history;; acute hyperglycemic/hypoglycemic events within 1 year, including:.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Mazdutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Mazdutide group and the comparison group ran side by side rather than switching.

As a double-blind Mazdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2025-09-30 with completion listed for 2027-09-30.

It ran at 14 sites in China (14).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): the rate of excess weight loss(EWL%) compared to baseline (time frame: At 48th week post procedure).

It also tracked 14 secondary outcomes, for example Assessing the rate of total body weight loss(TBWL%) compared to baseline, Assessing the change of waist circumference(centimeter, cm) compared to baseline, Assessing the change of hip circumference(centimeter, cm) compared to baseline, Assessing the change of blood pressure(incl. systolic blood pressure and diastolic blood pressure) compared to baseline（Hydrargyrum, mmHg）, Assessing the percentage change（%） of body fat or fat-free mass compared to baseline and Assessing the percentage change（%） of liver fat content or pancreatic fat content compared to baseline.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Mazdutide in 256 people.

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, all human trials.