Overweight , Obesity
Conditions
Brief summary
This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants. The study consists of two parts: Part 1, a single ascending dose (SAD) study in healthy participants with 8 dose cohorts; and Part 2, a multiple ascending dose (MAD) study in overweight or obese participants with 3 dose cohorts, with a dosing frequency of once weekly or once every 4 weeks. Approximately 103 participants will be enrolled. The primary endpoint is safety and tolerability, assessed by adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and ophthalmic examination. Secondary endpoints include single-dose and multiple-dose PK parameters, PD parameters (body weight, BMI, waist circumference, muscle mass, body fat percentage, visceral fat, subcutaneous fat, bone mineral density), and immunogenicity (anti-drug antibodies).
Interventions
DRUGMWN110
S1, S2, S3, S4, S5, S6, S7, S8; administered subcutaneously (SC)
DRUGPlacebo
administered SC
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
Yes
Inclusion criteria
1. Male or female participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1/3. 2. Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 20.0 to 40.0 kg/m\^2 (inclusive). 3. Female participants must have no plans for pregnancy or egg donation from 14 days before the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid pregnancy; male participants must have no plans for fathering a child or sperm donation from the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid causing partner pregnancy.
Exclusion criteria
1. Known or suspected allergy to the investigational product or its excipients, or history of severe allergy (including any food or drug allergy). 2. Body weight change \>5% within 3 months prior to screening (weight change % = \[maximum weight in 3 months - minimum weight in 3 months\] / maximum weight in 3 months x 100%). 3. Diagnosed with secondary overweight or obesity. 4. History of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis); serum amylase or lipase above the upper limit of normal. 5. Known history of disease or comorbidity affecting skeletal muscle protein. 6. At screening, the presence of active acne, pyogenic dermatosis, allergic dermatosis, inflammatory dermatosis, infectious dermatosis, unhealed skin wounds, extensive skin lesions, or skin abnormalities such as vegetations or masses, judged by the investigator as unsuitable for participation. 7. History of infectious disease within 4 weeks prior to screening (judged by the investigator as potentially significantly affecting safety evaluation), history of severe trauma, or history of major surgery within 3 months, or planned surgery during the study period. 8. At screening, any laboratory test meeting any of the following criteria: a) fasting blood glucose \>6.1 mmol/L or \<3.9 mmol/L; b) alanine aminotransferase, aspartate aminotransferase, or total bilirubin \>1.5 × upper limit of normal (ULN); c) estimated glomerular filtration rate \<70 mL/min/1.73 m² (CKD-EPI equation) or urinary protein positive (1+ or above); d) fasting triglycerides ≥3.42 mmol/L (Part 1) or \>5.64 mmol/L (Part 2); e) hemoglobin \<100 g/L (females) or \<110 g/L (males); f) blood uric acid (UA) \>540 μmol/L. 9. At screening, 12-lead electrocardiogram showing heart rate \<50 bpm or \>100 bpm, second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF \>460 ms (female) or \>450 ms (male), or other electrocardiogram abnormalities judged by the investigator as requiring pharmacological intervention. 10. Participants who have undergone dieting or weight-loss treatment within 30 days prior to the first dose, or who have experienced major changes in lifestyle habits. 11. Use of GLP-1 receptor agonists, weight-loss drugs, systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months before the first dose. 12. Engaged in strenuous muscle exercise, high-intensity resistance training, or regular muscle-strengthening activities within 30 days before the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) to the investigational product | From Day 1 to Day 169 | Incidence of treatment-emergent adverse events (TEAEs) |
| Number of participants with abnormal vital signs | From Day 1 to Day 169 | — |
| Number of participants with abnormal ECG readings | From Day 1 to Day 169 | — |
| Number of participants with abnormal physical examination findings | From Day 1 to Day 169 | — |
| Number of participants with abnormal clinical laboratory measurements | From Day 1 to Day 169 | — |
| Number of participants with abnormal ophthalmological examination findings | From Day 1 to Day 169 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration (Cmax) | From Day 1 to Day 57 | Cmax of MWN110 |
| Time to Reach Maximum Concentration (Tmax) | From Day 1 to Day 57 | Tmax of MWN110 |
| Under the Concentration Versus Time Curve (AUC) | From Day 1 to Day 57 | Area AUC of MWN110 |
| Apparent Terminal Elimination Half-life (t1/2) | From Day 1 to Day 57 | t1/2 of MWN110 |
| Steady State Maximum Concentration (Cmax,ss) | From Day 1 to Day 169 | Cmax,ss of MWN110 |
| Time to Reach Maximum Concentration at Steady State (Tmax,ss) | From Day 1 to Day 169 | Tmax,ss of MWN110 |
| Steady State Area Under the Concentration Versus Time Curve (AUCss) | From Day 1 to Day 169 | AUCss of MWN110 |
| Steady State Apparent Terminal Elimination Half-life (t1/2,ss) | From Day 1 to Day 169 | t1/2,ss of MWN110 |
| Change from Baseline in Body Weight | From Day 1 to Day 169 | Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point. |
| Change from Baseline in Body Mass Index (BMI) | From Day 1 to Day 169 | Change from baseline in BMI is calculated by subtracting the baseline BMI value from the post-treatment BMI value at a specified time point. |
| Change from Baseline in Waist Circumference | From Day 1 to Day 169 | Change from baseline in waist circumference is calculated by subtracting the baseline waist measurement from the post-treatment waist measurement at a specified time point. |
| Change from Baseline in Muscle Mass | From Day 1 to Day 169 | Change from baseline in muscle mass is calculated by subtracting the baseline muscle mass measurement from the post-treatment muscle mass measurement at a specified time point. |
| Change from Baseline in Body Fat Percentage (BFP) | From Day 1 to Day 169 | Change from baseline in BFP is calculated by subtracting the baseline BMI value from the post-treatment BFPvalue at a specified time point. |
| Incidence and Titers of Anti-drug Antibody (ADA) | From Day 1 to Day 169 | — |
Countries
China
Contacts
CONTACTWanxiang Chen
Outcome results
None listed