Tests MWN109 injection in adults with overweight or obesity

Trial details

Who runs it

Shanghai Minwei Biotechnology Co., Ltd

Trial code

NCT07778693

Record updated

21 August 2026

Original description

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity.Read full original descriptionShow less

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity.

Approximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose.

The study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.

Inclusion: Male or female aged 18 to 65 years (inclusive) at the time of signing the informed consent form; Body weight ≥ 70 kg (males) or ≥ 60 kg (females), with BMI ≥ 28 kg/m² (obesity), or 24 kg/m² ≤ BMI < 28 kg/m² (overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, polycystic ovary syndrome); Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead ECG); Self-reported or documented history of dietary and exercise-based weight management for at least 12 weeks prior to screening, with < 5.0% weight change during the 12 weeks prior to screening, and ability to maintain the required diet and exercise behavior during the study; Participants of childbearing potential must agree to use highly effective contraception from 14 days before signing the ICF until 4 months after the last dose, with no plans for pregnancy or oocyte donation; male participants must agree to use highly effective contraception from signing the ICF until 4 months after the last dose, with no plans for fathering children or sperm donation.

Exclusion: Known allergic constitution (allergy to 3 or more foods or drugs), or allergy to GLP-1 receptor agonists or any component of the investigational product, or severe allergic diseases at screening, or history of severe drug allergy; Use of any anti-hyperglycemic agents, weight-affecting medications, or prescription weight-loss medications for weight control within 12 weeks prior to screening; over-the-counter weight-loss medications or appetite suppressants within 4 weeks; Previous treatment with MWN109 injection; Laboratory abnormalities: ALT or AST ≥ 3×ULN; total bilirubin ≥ 1.5×ULN; eGFR < 60 mL/min/1.73m²; hemoglobin < 110 g/L (males) or < 100 g/L (females); serum calcitonin ≥ 35 ng/L; TSH > 6.0 or < 0.4 mIU/L; fasting triglycerides ≥ 5.64 mmol/L; serum amylase or lipase > 2.0×ULN; Known or screening-detected ECG abnormalities with significant safety risk, including: uncontrolled arrhythmias, second-degree or third-degree AV block, ST-T changes suggesting myocardial ischemia, QTcF > 450 ms, family history of long QT or Brugada syndrome; Has a medical history or evidence of any of the following conditions: secondary or drug-induced overweight or obesity; diagnosis of type 1 or type 2 diabetes mellitus in the past or at screening, or at least one laboratory finding suggestive of diabetes identified at screening: HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol/L, random plasma glucose ≥ 11.1 mmol/L, or 2-hour plasma glucose during the oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L; acute or chronic pancreatitis; gallstones/cholecystitis (with exceptions); thyroid C-cell carcinoma or MEN 2A/2B; prior bariatric surgery (with exceptions); moderate or severe depression (PHQ-9 ≥ 15), other severe psychiatric disorders, or suicidal risk; malignancy within 5 years (with exceptions); cardiac disease within 6 months; premature beats or tachycardia; cerebrovascular event within 6 months; uncontrolled hypertension; thyroid dysfunction; gastric emptying abnormalities; organ transplant history; autoimmune disease; previous or planned weight-loss treatment; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT07778693