Overweight , Obesity
Conditions
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.
Interventions
Sponsors
Shanghai Minwei Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18 to 65 years (inclusive) at the time of signing the informed consent form; 2. 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); 3. Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead ECG); 4. 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; 5. 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 criteria
1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. Pregnant or breastfeeding women. 7. Previous treatment with MWN109 injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change from Baseline in Body Weight at Week 52 | Baseline, Week 52 | Percentage change in body weight from baseline to Week 52. |
| Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 52 | Baseline, Week 52 | Proportion of participants with a body weight reduction of 5% or more from baseline at Week 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 52 | Baseline, Week 52 | Proportion of participants with a body weight reduction of 10% or more from baseline at Week 52. |
| Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 52 | Baseline, Week 52 | Proportion of participants with a body weight reduction of 15% or more from baseline at Week 52. |
| Change in Waist Circumference from Baseline at Week 52 | Baseline, Week 52 | Change in waist circumference from baseline to week 52. |
| Change from Baseline in Waist-to-Height Ratio (WHtR) | up to 52 weeks | Change in WHtR from baseline throughout the study. |
| Change from Baseline in Body Mass Index (BMI) | up to 52 weeks | Change in BMI from baseline throughout the study. |
| Change from Baseline in Neck Circumference | up to 52 weeks | Change in neck circumference from baseline throughout the study. |
| Change from Baseline in Blood Lipid Parameters | up to 52 weeks | Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study. |
| Change from Baseline in Blood Pressure | up to 52 weeks | Change in systolic and diastolic blood pressure from baseline throughout the study. |
| Change from Baseline in Glucose Metabolism Parameters | up to 52 weeks | Change in glucose metabolism parameters (including fasting plasma glucose, HbA1c, fasting insulin, HOMA-IR) from baseline throughout the study.\] |
| Change from Baseline in Serum Uric Acid | up to 52 weeks | Change in serum uric acid from baseline throughout the study. |
| Change from Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) | up to 52 weeks | Change in UACR from baseline throughout the study. |
| Change in Liver Fat Content (LFC) from Baseline at Week 52 | up to 52 weeks | Change in LFC from baseline to week 52. |
| Change in IWQOL-Lite-CT Score from Baseline at Week 24 and Week 52 | Baseline, Week 24, Week 52 | Change in IWQOL-Lite-CT score from baseline to Week 24 and Week 52. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | up to 52 weeks | Number and proportion of participants with treatment-emergent adverse events throughout the study. |
Countries
China
Contacts
CONTACTWanxiang Chen
Outcome results
None listed