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CompletedPhase 2

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

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

NCT IDNCT07791654
Org study IDMWN109-II-WL

Timeline

Milestones

Study start2025-08-23actual
Primary completion2026-03-21actual
Study completion2026-03-21actual
Study first posted2026-08-28actual
Last update posted2026-08-28actual

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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:

-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.

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
Glycemic / diabetes
3
Cardiometabolic biomarkers
3
Safety / tolerability / PK
1

Weight & body composition

9 endpoints
Primary/protocol endpoint

Percentage change in body weight compared to baseline after 24 weeks of drug administration

Time frame:Baseline, Week 24

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight from baseline over time

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body mass index (BMI) over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Change from baseline in fasting insulin over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG) over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in glycated hemoglobin (HbA1c) over time

Time frame:up to 24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change from baseline in lipid profile over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in blood pressure over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in serum uric acid over time

Time frame:up to 24 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:up to 24 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.