Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)

What Was Tested

This registered phase 4 trial tested Mazdutide.

Prediabetes affects millions of adults worldwide and carries a high risk of progression to type 2 diabetes.

Mazdutide is a once-weekly injectable drug that activates both GLP-1 and glucagon receptors, lowering blood sugar and body weight simultaneously.

This study (DREAM-PRE) tests whether mazdutide can help adults with prediabetes return to normal blood sugar levels.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

Reversal to Normal Glucose Regulation (NGR) is achievable but underexplored as a primary clinical endpoint.

Mazdutide (IBI362) is a GLP-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist.

Beyond GLP-1R-mediated glucose-dependent insulin secretion and appetite suppression, GCGR co-agonism enhances hepatic fatty acid oxidation and energy expenditure.

This dual mechanism may address the overlapping pathophysiology of prediabetes - beta-cell dysfunction, insulin resistance, ectopic lipid accumulation, and excess adiposity - more comprehensively than GLP-1R monoagonists alone.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Voluntarily signed written informed consent prior to any study procedures. Age 18 to 75 years (inclusive) at the time of signing informed consent; male or female. Prediabetes confirmed by central laboratory at screening, meeting at least one of the following criteria per Chinese Diabetes Society (CDS) standards, and not meeting diagnostic criteria for diabetes:. BMI ≥22.0 kg/m² at screening. Able to understand study requirements, complete all planned visits and examinations, self-administer once-weekly subcutaneous injections, and use the study app for daily monitoring.

The full record lists 10 inclusion and 21 exclusion criteria; among the exclusions: prior bariatric or metabolic surgery including roux-en-y gastric bypass, sleeve gastrectomy, adjustable gastric banding, biliopancreatic diversion, intragastric balloon placement, or other bariatric surgery; prior history of acute pancreatitis (confirmed by imaging or surgery) or chronic pancreatitis; or serum amylase \>3× uln or serum lipase \>3× uln at screening; NYHA Class III or IV heart failure. (NYHA Class I and II are not grounds for exclusion.).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2026-07 with completion listed for 2028-06.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 24 (time frame: Week 24).

It also tracked 29 secondary outcomes, for example Change from Baseline in HbA1c, Change from Baseline in Fasting Plasma Glucose, Change from Baseline in OGTT 2-Hour Plasma Glucose, Proportion of Participants Maintaining Normal Glucose Regulation (NGR) at Week 48, Cumulative Incidence of Progression to Type 2 Diabetes and Proportion of Week-24 NGR Responders Maintaining NGR at Week 48.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Mazdutide in 150 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.