Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial

What Was Tested

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

It had two arms (groups): one (experimental) and placebo (placebo comparator).

Placebo, SC, once a week\* 32weeks;.

The registry classes the interventions as drug.

More on the Plan

This study is a 44-week, multicenter, randomized, double-blind, placebo-controlled clinical trial.

The primary objective is to evaluate the potential diabetes remission effects of mazdutide on cognitive dysfunction in type 2 diabetes.

Who Took Part

249 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: Duration of type 2 diabetes ≤5 years at screening. 5.BMI≥24 kg/m2 at screening. 6.A stable diet and exercise lifestyle could be maintained during the study period. Subjects voluntarily sign informed consent and agree to strictly follow the requirements of this protocol.

The full record lists 3 inclusion and 24 exclusion criteria; among the exclusions: oral antidiabetic drugs other than background medications within 2 months before screening; use of chinese herbal medicine, other traditional medicines and health products with hypoglycemic effect within 2 months before screening; were receiving chronic (\> 2 weeks) systemic glucocorticoids or had received glucocorticoids within 4 weeks before screening (topical, intraocular, intranasal, or inhaled administration were excluded).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.

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

It started in 2026-09-30 with completion listed for 2028-08-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44 (time frame: Baseline, 44 weeks).

It also tracked 5 secondary outcomes, for example HbA1c change from baseline at week 32, Change from Baseline in Fasting Plasma Glucose and Percent Change from Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Mazdutide in 249 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.