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CompletedPhase 1

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

A Randomized, Double-Blind, Placebo-Controlled Phase 1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Subcutaneous Administrations of MWN109 Injection in Chinese Non-Diabetic Participants With Overweight or Obesity

Asset

MWN109

GLP-1 / GIP / glucagon triple

Listed sites

1

Recruiting sites

-

Actual enrollment

40

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-35

Primary endpoint

•Adverse events (AEs) and serious adverse events (SAEs)

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 IDNCT07787728
Org study IDMWN109-Ⅰb

Timeline

Milestones

Study start2025-07-14actual
Primary completion2025-12-16actual
Study completion2025-12-16actual
Study first posted2026-08-26actual
Last update posted2026-10-28actual

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 between 18 and 65 years old (inclusive of 18 and 65 years old), as determined by the date of signing the informed consent form.

2. Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a BMI ranging from 27.0 to 35.0 kg/m2.

3. Resting heart rate ≥ 55 beats per minute and ≤ 90 beats per minute (results of 12-lead electrocardiogram before randomization).

4. 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.

5. 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.

Exclusion criteria

1. 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.

2. 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.

3. 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).

4. 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.

5. 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.
-Participants with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at the time of screening) after treatment, or those with untreated blood pressure reaching the above-mentioned criteria at the time of screening.
-Abnormal thyroid function that cannot be controlled with a stable drug dosage at the time of screening, or abnormal thyroid function test results with clinical significance that require initiation of treatment at the time of screening.
-Abdominal ultrasound at the time of screening indicates symptomatic gallbladder polyps or other gallbladder diseases that require treatment, or gallbladder diseases with symptoms that the investigator deems require treatment.
-Clinically significant gastric emptying abnormalities, gastric reflux disease, active gastrointestinal diseases, etc., present at the time of screening.

Endpoints (13)

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

Safety / tolerability / PK
11
Other (unclassified)
2

Safety / tolerability / PK

11 endpoints
Primary/protocol endpoint

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

Time frame:From Day 1 to Day 113

event count, event

Secondary/protocol endpoint

Maximum Concentration (Cmax)

Time frame:From Day 1 to Day 60

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Concentration (Tmax)

Time frame:From Day 1 to Day 60

time to event, event

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 60

descriptive

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 60

descriptive

Secondary/protocol endpoint

Elimination Half-Life (t1/2)

Time frame:From Day 1 to Day 60

concentration, descriptive

Secondary/protocol endpoint

Steady State Maximum Concentration (Cmax,ss)

Time frame:From Day 1 to Day 113

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Concentration at Steady State (Tmax,ss)

Time frame:From Day 1 to Day 113

time to event, event

Secondary/protocol endpoint

Steady State Apparent Terminal Elimination Half-life (t1/2,ss)

Time frame:From Day 1 to Day 113

concentration, descriptive

Secondary/protocol endpoint

Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)

Time frame:From Day 1 to Day 113

concentration, descriptive

Secondary/protocol endpoint

Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)

Time frame:From Day 1 to Day 113

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Steady State Minimum Concentration (Cmin,ss)

Time frame:From Day 1 to Day 113

concentration, descriptive

Secondary/protocol endpoint/low confidence

Steady State Concentration (Cav,ss)

Time frame:From Day 1 to Day 113

concentration, descriptive

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.