Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity

NCT07787728 | Completed Phase 1

• 1 other identifier: MWN109-Ⅰb
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese non-diabetic participants with overweight or obesity. A total of 40 participants were enrolled in the study. All participants were stratified and randomized by gender in blocks, and randomly assigned to 4 dose groups at a ratio of 1:1:1:1, with 10 participants in each group(8 participants received MWN109 injection, and 2 received placebo). Each treatment group will use a dose titration method to reach the target dose. The study includes a maximum screening period of up to 2 weeks, a 14-week treatment period and a 2-week follow-up period, totaling 18 weeks. The primary endpoint is the incidence of adverse events. The secondary endpoint is the pharmacokinetic characteristics.

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Safety and tolerability assessed by the incidence of AEs and SAEs.

  From Day 1 to Day 113

Secondary Outcomes (12)

• Maximum Concentration (Cmax)

  From Day 1 to Day 60

• Time to Reach Maximum Concentration (Tmax)

  From Day 1 to Day 60

• Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)

  From Day 1 to Day 60

• Area Under the Curve From Time 0 to Infinity (AUC0-inf)

  From Day 1 to Day 60

• Elimination Half-Life (t1/2)

  From Day 1 to Day 60

Study Arms (5)

MWN109 Cohort 1

EXPERIMENTAL

Drug: MWN109 1

MWN109 Cohort 2

EXPERIMENTAL

Drug: MWN109 2

MWN109 Cohort 3

EXPERIMENTAL

Drug: MWN109 3

MWN109 Cohort 4

EXPERIMENTAL

Drug: MWN109 4

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MWN109 1 DRUG

Administered SC, QW, 14 weeks

MWN109 Cohort 1

MWN109 2 DRUG

Administered SC, QW, 14 weeks

MWN109 Cohort 2

MWN109 3 DRUG

Administered SC, QW, 14 weeks

MWN109 Cohort 3

MWN109 4 DRUG

Administered SC, QW, 14 weeks

MWN109 Cohort 4

Placebo DRUG

Administered SC, QW, 14 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 individuals aged between 18 and 65 years old (inclusive of 18 and 65 years old), as determined by the date of signing the informed consent form.
• Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a BMI ranging from 27.0 to 35.0 kg/m2.
• Resting heart rate ≥ 55 beats per minute and ≤ 90 beats per minute (results of 12-lead electrocardiogram before randomization).
• Self-reported or documented weight change before the screening period of 12 weeks was less than 5.0%, and the participant can maintain their original diet and lifestyle during the trial period.
• Participants must have no pregnancy plans from the time of signing the informed consent form until 4 months after the last dose of the investigational drug.

You may not qualify if:

• Individuals with a known allergy to GLP - 1 receptor agonist drugs or the excipient components of MWN109 injection, or those with severe allergic diseases or a severe allergic constitution at the time of screening.
• Used GLP-1 receptor agonists or similar drugs targeting the same site, drugs that affect body weight, or weight-loss drugs within 12 weeks before screening.
• Laboratory abnormalities: HbA1c ≥ 6.5%, or fasting blood glucose ≥ 7.0 mmol/L, or 2-hour blood glucose in the OGTT≥ 11.1 mmol/L (participants with fasting blood glucose between 6.1 and 6.9 mmol/L at the time of screening need to undergo the OGTT), ALT or AST ≥ 2.5ULN, or total serum bilirubin ≥ 1.5ULN. Serum amylase or serum lipase ≥ 1.5ULN. eGFR\< 60 mL/min/1.73 m². Serum calcitonin level ≥ 35 ng/L (pg/mL). TSH\> 6.0 mIU/L or \< 0.4 mIU/L. Triglycerides ≥ 5.64 mmol/L (500 mg/dL). HGB\< 110 g/L (for males) or \< 100 g/L (for females).
• ECG shows second- or third-degree atrioventricular block, long QT syndrome (QTcF \> 470 ms for females or \> 450 ms for males), pre-excitation syndrome, or other ECG abnormalities that the investigator deems require drug intervention.
• Participants with a history or evidence of any of the following diseases:
• Obesity secondary to other diseases or drug use.
• Previously or currently diagnosed with type 1 or type 2 diabetes at the time of screening.
• Previously or currently diagnosed with acute or chronic pancreatitis, or pancreatic injury at the time of screening;.
• Previous diagnosis of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia type 2A or 2B, or with a relevant family history.
• Previously undergone gastric weight-loss surgery, or planning to undergo weight-loss surgery, liposuction, or abdominal fat-reduction surgery during the study, which can significantly affect body weight.
• A history of past or current depression, other severe mental illnesses, or a history of suicidal tendencies or behaviors.
• Diagnosed with a malignant tumor within 5 years before screening (except for cured carcinoma in situ), or with a potential malignant tumor as evaluated at the time of screening.
• A history of any of the following heart diseases within 6 months before screening.
• Suffered from hemorrhagic or ischemic stroke within 6 months before screening and deemed ineligible to participate in this clinical trial by the investigator.
• Experienced severe hypoglycemia or recurrent (≥ 2 times within 6 months) symptomatic hypoglycemia within 6 months before screening.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, 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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 24, 2026
• First Posted: August 26, 2026
• Study Start: July 14, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)