Clinical Trial

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

Study acronym: DREAM-PRE
Not Yet Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
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. Approximately 150 adults aged 18-75 years with prediabetes and BMI ≥22 kg/m² will be randomly assigned in equal numbers to one of three groups: mazdutide 4 mg once weekly, mazdutide 6 mg once weekly, or placebo once weekly. All participants also receive standardized diet and exercise guidance throughout the study. Treatment lasts 24 weeks, followed by 24 weeks of off-drug follow-up to see whether any benefits are maintained. The main question is: what proportion of participants achieve completely normal blood sugar (normal HbA1c, fasting glucose, AND glucose tolerance test) after 24 weeks of treatment? The study is conducted at approximately 10 hospitals across China.
Trial Details
NCT Number NCT07654062
Lead Sponsor Shandong Provincial Hospital
Collaborators: Innovent Biologics, Inc.
Conditions Prediabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance (Prediabetes)
Enrollment 150 participants
Start Date 2026-07
Primary Completion 2028-06 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-17