Overweight , Obesity
Conditions
Brief summary
This is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial to preliminarily evaluate the efficacy, safety, and PK of MWN109 tablets administered orally once daily in non-diabetic participants with overweight or obesity. Approximately 240 participants will be enrolled. All participants will be stratified by gender (male or female) and then randomized 1:1:1:1:1 to 5 treatment groups, with approximately 48 participants per group. All treatment groups will implement dose titration to achieve the target dose. This study consists of a screening period of up to 2 weeks, a treatment period of 20 weeks, and a follow-up period of 2 weeks, totaling 24 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 20 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 20 weeks of treatment, as well as the change in waist circumference relative to the baseline.
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 individuals aged 18 to 65 years (inclusive), as determined by the date of signing the informed consent form; 2. Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI \< 30 kg/m² (overweight) and at least one weight-related comorbidity (such as hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular diseases, polycystic ovary syndrome, etc.); 3. Resting heart rate ≥ 55 and ≤ 90 beats per minute (based on 12-lead electrocardiogram results during screening and before randomization); 4. The subject has undertaken weight management via diet and exercise alone for at least 12 weeks prior to screening, with a weight change of \<5.0% (self-reported), and is able to continue the same diet-and-exercise-based weight management during the study period. 5. Participants must have no pregnancy plans from the time of signing informed consent until 3 months after the last dose of the investigational product, must use effective contraception to avoid pregnancy or partner pregnancy, and must have no plans to donate sperm or eggs.
Exclusion criteria
1. It is known that the subject has an allergic constitution, or is allergic to any component of glucagon-like peptide-1 (GLP-1) receptor agonist drugs or investigational medicinal products, or has a severe allergic disease during screening, or has a history of severe drug allergy in the past; 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. It is known or discovered during screening that the electrocardiogram is abnormal and there is a significant safety risk, or further diagnosis and treatment are required, including but not limited to: arrhythmias that cannot be controlled or require drug treatment such as persistent ventricular tachycardia, second or third degree atrioventricular block, QTcF \> 450 ms, long QT syndrome family history or Brugada syndrome family history, etc. 5. There is a history or evidence of any of the following diseases: secondary or drug-induced overweight or obesity; previous diagnosis of type 1 or type 2 diabetes, or at least one laboratory test indicator suggesting diabetes during screening; previous diagnosis of acute or chronic pancreatitis, or pancreatic injury; history of gallstones or cholecystitis during screening; previous diagnosis of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia type 2A or 2B, or a related family history; previously undergone gastric weight loss surgery or other weight loss surgeries, or plans to undergo weight loss surgery, liposuction, abdominal lipolysis, or other surgeries that significantly affect body weight during the study period; previously had moderate or severe depression; diagnosed with a malignant tumor within the previous 5 years or evaluated as having potential malignant tumors during screening; history of any heart disease within 6 months before screening or before randomization; cerebrovascular accident within 6 months before screening or before randomization; uncontrolled hypertension during the screening period; history of hyperthyroidism or hypothyroidism, or clinically significant abnormal thyroid function test results during screening; clinically significant gastric emptying abnormalities, requires long-term use of drugs that directly affect gastrointestinal motility, or active gastrointestinal diseases during screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in body weight compared to baseline after 20 weeks of drug administration | Baseline, week 20 | Percentage change in body weight from baseline to Week 20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in blood pressure over time | up to 20 weeks | Change in systolic and diastolic blood pressure from baseline throughout the study. |
| Change from baseline in fasting insulin over time | up to 20 weeks | Change in fasting serum insulin levels from baseline throughout the study. |
| Change from baseline in fasting plasma glucose (FPG) over time | up to 20 weeks | Change in fasting plasma glucose levels from baseline throughout the study. |
| Change from baseline in glycated hemoglobin (HbA1c) over time | up to 20 weeks | Change in HbA1c levels from baseline throughout the study. |
| Change from baseline in serum uric acid over time | up to 20 weeks | Change in serum uric acid levels from baseline throughout the study. |
| Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at week 20 | Baseline, week 20 | Proportion of participants with a body weight reduction of 5% or more from baseline at week 20. |
| Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at week 20 | Baseline, week 20 | Proportion of participants with a body weight reduction of 10% or more from baseline at week 20. |
| Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at week 20 | Baseline, week 20 | Proportion of participants with a body weight reduction of 15% or more from baseline at week 20. |
| Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at week 20 | Baseline, week 20 | Proportion of participants with a body weight reduction of 20% or more from baseline at week 20. |
| Change from baseline in waist circumference over time | up to 20 weeks | Change in waist circumference from baseline to week 20. |
| Change from baseline in body mass index (BMI) over time | up to 20 weeks | Change in BMI from baseline throughout the study. |
| Change from baseline in body weight over time | Baseline, week 20 | Change in body weight from baseline to week 20. |
| Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score over time | up to 20 weeks | Change in IWQOL-Lite-CT score from baseline throughout the study. The IWQOL-Lite-CT, a 20-item patient-reported outcome (PRO) tool, evaluates weight-related physical and psychosocial function. Each of its 5 response choices (A-E) yields a score from 1 to 5. Total scores range from 20 to 100. Higher composite and total scores are associated with better participant-reported functioning. |
| Change from baseline in lipid profile over time | up to 20 weeks | Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | up to 20 weeks] | Number and proportion of participants with treatment-emergent adverse events throughout the study. |
Countries
China
Outcome results
None listed