Phase 2 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity

NCT07804810 | Completed Phase 2

• 1 other identifier: MWN105-II-WL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity. Approximately 120 participants will be randomized to receive different dose levels of MWN105 Injection or matching placebo, administered subcutaneously once weekly for a total treatment duration of 24 weeks, with dose titration from 15 mg to the target dose. The primary endpoint is the percent change from baseline in body weight at Week 24. Secondary endpoints include changes in body weight and metabolic parameters, bone mineral density, pharmacokinetic parameters, immunogenicity, and safety.

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage Change from Baseline in Body Weight at Week 24.

  Baseline, Week 24

Secondary Outcomes (14)

• Change from baseline in body weight over time

  up to 24 weeks

• Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 24

  Baseline, Week 24

• Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 24

  Baseline, Week 24

• Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 24

  Baseline, Week 24

• Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 24

  Baseline, Week 24

Study Arms (4)

MWN105 Cohort 1

EXPERIMENTAL

Drug: MWN105 1

MWN105 Cohort 2

EXPERIMENTAL

Drug: MWN105 2

MWN105 Cohort 3

EXPERIMENTAL

Drug: MWN105 3

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MWN105 2 DRUG

Administered SC, QW, 24 weeks

MWN105 Cohort 2

MWN105 1 DRUG

Administered SC, QW, 24 weeks

MWN105 Cohort 1

MWN105 3 DRUG

Administered SC, QW, 24 weeks

MWN105 Cohort 3

Placebo DRUG

Administered SC, QW, 24 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 participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF).
• Body weight ≥ 70 kg (male) or ≥ 60 kg (female), with body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI \< 30 kg/m² (overweight) accompanied by at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, or polycystic ovary syndrome).
• Self-reported or documented diet and exercise control of body weight for 12 weeks or more, with body weight change of less than 5.0% within 12 weeks prior to screening.

You may not qualify if:

• Known hypersensitivity to GLP-1 receptor agonists, any component of the investigational product, or history of severe allergic disease or severe drug allergy.
• Use of medications that may affect glucose metabolism or body weight before screening, including antidiabetic drugs, systemic glucocorticoids, psychotropic drugs associated with weight change, prescription weight-loss drugs within 12 weeks, or over-the-counter weight-loss drugs/appetite suppressants within 4 weeks.
• Clinically significant laboratory abnormalities at screening or before randomization, including:
• ALT or AST ≥3 × ULN, or TBIL ≥1.5 × ULN.
• eGFR \<60 mL/min/1.73 m².
• Hemoglobin \<110 g/L in males or \<100 g/L in females.
• Calcitonin ≥35 ng/L.
• TSH \>6.0 or \<0.4 mIU/L.
• Fasting triglycerides ≥5.64 mmol/L.
• Amylase or lipase \>2 × ULN.
• History or presence of clinically significant diseases or conditions that may affect body weight, safety, or study assessments, including:
• Secondary or drug-induced overweight/obesity.
• Type 1 or type 2 diabetes mellitus, or laboratory evidence of diabetes (HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or random/2-hour OGTT plasma glucose ≥11.1 mmol/L).
• Acute or chronic pancreatitis or pancreatic injury.
• Gallstones or cholecystitis, except adequately treated cases without residual disease.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: September 3, 2025
• Primary Completion: March 21, 2026
• Study Completion: April 16, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)