Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity

NCT07778693 | Not Yet Recruiting Phase 3

• 1 other identifier: MWN109-Ⅲ-WL
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage Change from Baseline in Body Weight at Week 52

  Percentage change in body weight from baseline to Week 52.

  Baseline, Week 52

• Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 52

  Proportion of participants with a body weight reduction of 5% or more from baseline at Week 52.

  Baseline, Week 52

Secondary Outcomes (14)

• Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 52

  Baseline, Week 52

• Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 52

  Baseline, Week 52

• Change in Waist Circumference from Baseline at Week 52

  Baseline, Week 52

• Change from Baseline in Waist-to-Height Ratio (WHtR)

  up to 52 weeks

• Change from Baseline in Body Mass Index (BMI)

  up to 52 weeks

Study Arms (4)

MWN109 Cohort 1

EXPERIMENTAL

Drug: MWN109 1

MWN109 Cohort 2

EXPERIMENTAL

Drug: MWN109 2

MWN109 Cohort 3

EXPERIMENTAL

Drug: MWN109 3

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MWN109 1 DRUG

Administered SC, QW, 52 weeks

MWN109 Cohort 1

MWN109 2 DRUG

Administered SC, QW, 52 weeks

MWN109 Cohort 2

MWN109 3 DRUG

Administered SC, QW, 52 weeks

MWN109 Cohort 3

Placebo DRUG

Administered SC, QW, 52 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Previous treatment with MWN109 injection.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wanxiang Chen

CONTACT

13359015677; chenwanxiang@minweibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

CN (1)