A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity
Lead sponsor
Asset
MWN109
GLP-1 / GIP / glucagon triple
Listed sites
1
Recruiting sites
-
Actual enrollment
120
Study population
Obesity / overweight
Eligibility highlights
•BMI ≥30
Primary endpoint
•Body weight compared
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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. Self-reported or documented weight control through diet and exercise for at least 12 weeks, with a weight change of less than 5.0% within the 12 weeks prior to screening.
5. No pregnancy plans from the date of signing the informed consent until 4 months after the last dose of the investigational drug; must voluntarily use effective contraception and have no plans for sperm or egg donation.
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:
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:
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
9 endpointsPercentage change in body weight compared to baseline after 24 weeks of drug administration
Time frame:Baseline, Week 24
percent change from baseline, improvement
Change in body weight from baseline over time
Time frame:Baseline, Week 24
change from baseline, improvement
Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 24
Time frame:Baseline, Week 24
threshold achievement, improvement
Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 24
Time frame:Baseline, Week 24
threshold achievement, improvement
Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 24
Time frame:Baseline, Week 24
threshold achievement, improvement
Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 24
Time frame:Baseline, Week 24
threshold achievement, improvement
Change from baseline in waist circumference over time
Time frame:up to 24 weeks
change from baseline, improvement
Change from baseline in body mass index (BMI) over time
Time frame:up to 24 weeks
change from baseline, improvement
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score over time
Time frame:up to 24 weeks
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange from baseline in fasting insulin over time
Time frame:up to 24 weeks
change from baseline, improvement
Change from baseline in fasting plasma glucose (FPG) over time
Time frame:up to 24 weeks
change from baseline, improvement
Change from baseline in glycated hemoglobin (HbA1c) over time
Time frame:up to 24 weeks
change from baseline, improvement
Cardiometabolic biomarkers
3 endpointsChange from baseline in lipid profile over time
Time frame:up to 24 weeks
change from baseline, improvement
Change from baseline in blood pressure over time
Time frame:up to 24 weeks
change from baseline, improvement
Change from baseline in serum uric acid over time
Time frame:up to 24 weeks
change from baseline, improvement
Safety / tolerability / PK
1 endpointIncidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame:up to 24 weeks
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.