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

Sponsor
Shandong Provincial Hospital
Study ID
NCT07654062
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Impaired Fasting Glucose
  • Impaired Glucose Tolerance (Prediabetes)
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    GLP-1 receptor/glucagon receptor (GLP-1R/GCGR) dual agonist, administered by subcutaneous injection once weekly using a pre-filled pen device. Arm 1 (4 mg): titration from 2 mg QW (weeks 0-4) to 4 mg QW (weeks 5-24). Arm 2 (6 mg): titration from 2 mg QW (weeks 0-4) to 4 mg QW (weeks 5-8) to 6 mg QW (weeks 9-24). Injection sites: abdomen, anterior-lateral thigh, or lateral upper arm, rotated at each injection.
  • Placebo — DRUG
    Matching placebo for mazdutide, administered by subcutaneous injection once weekly using a pre-filled pen device identical in appearance, color, volume, and packaging to the active drug pen. Titration schedule mirrors the 6 mg mazdutide arm to maintain blinding.
  • Standardized Lifestyle Intervention — BEHAVIORAL
    Structured dietary modification with an energy deficit of 500-750 kcal/day and moderate-intensity aerobic exercise of at least 150 minutes per week, maintained throughout the 48-week study period. Applied equally to all three arms.

Study Details

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.

Key Dates

First listed
Jun 17, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Mazdutide 4 mg
    Mazdutide 2 mg once weekly subcutaneous injection for 4 weeks (titration), then 4 mg once weekly for 20 weeks. All participants receive standardized lifestyle intervention (dietary modification and aerobic exercise) throughout the 48-week study period.
  • Experimental: Mazdutide 6 mg
    Mazdutide 2 mg once weekly subcutaneous injection for 4 weeks, then 4 mg once weekly for 4 weeks, then 6 mg once weekly for 16 weeks. All participants receive standardized lifestyle intervention throughout the 48-week study period.
  • Placebo Comparator: Placebo
    Matching placebo once weekly subcutaneous injection. Placebo pens are identical to active drug pens in appearance, color, volume, and packaging. The titration schedule mirrors the 6 mg arm (weeks 0-4, 5-8, 9-24) to maintain blinding. All participants receive standardized lifestyle intervention throughout the 48-week study period.

Primary Outcome Measure

Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 24 [ Time Frame: Week 24 ]

Central Contacts

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