Randomized trial investigates Mazdutide's efficacy for prediabetes reversal in Chinese adults

Prediabetes affects millions globally, carrying a significant risk of progression to type 2 diabetes. Current interventions often involve lifestyle changes, which can be challenging to sustain, and pharmacological options are limited for disease reversal. Mazdutide, a once-weekly injectable dual GLP-1 and glucagon receptor agonist, has shown promise in lowering blood sugar and inducing weight loss in individuals with overweight or obesity. This trial aims to determine if Mazdutide can effectively normalize blood sugar levels in adults with prediabetes, potentially preventing progression to full-blown diabetes.

The DREAM-PRE study is a 24-week, randomized, double-blind, placebo-controlled trial involving approximately 150 Chinese adults aged 18-75 years with prediabetes and a BMI ≥22 kg/m². Participants are randomly assigned in equal numbers to receive either mazdutide 4 mg once weekly, mazdutide 6 mg once weekly, or placebo once weekly via subcutaneous injection. All groups also receive standardized diet and exercise guidance. The primary endpoint is the proportion of participants achieving completely normal blood sugar (normal HbA1c, fasting glucose, AND glucose tolerance test) after 24 weeks of treatment, followed by a 24-week off-drug follow-up period.

This abstract describes the design of the DREAM-PRE trial, which is currently investigating the potential of mazdutide to reverse prediabetes. It does not present actual results, but rather outlines the study's primary objective and methodology. The main question the trial seeks to answer is the proportion of participants who will achieve completely normal blood sugar levels after 24 weeks of treatment. This normalization is strictly defined as meeting criteria for normal HbA1c, normal fasting glucose, AND a normal oral glucose tolerance test. The study is powered to detect a statistically significant difference in this primary endpoint between the mazdutide 4 mg and 6 mg arms compared to placebo. Secondary endpoints will likely include changes in body weight, HbA1c, fasting glucose, and safety profiles across the treatment groups. The trial's design aims to provide robust evidence on mazdutide's efficacy in preventing the progression from prediabetes to type 2 diabetes.