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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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:
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 endpointsIncidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame:From Day 1 to Day 113
event count, event
Maximum Concentration (Cmax)
Time frame:From Day 1 to Day 60
concentration, descriptive
Time to Reach Maximum Concentration (Tmax)
Time frame:From Day 1 to Day 60
time to event, event
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame:From Day 1 to Day 60
descriptive
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame:From Day 1 to Day 60
descriptive
Elimination Half-Life (t1/2)
Time frame:From Day 1 to Day 60
concentration, descriptive
Steady State Maximum Concentration (Cmax,ss)
Time frame:From Day 1 to Day 113
concentration, descriptive
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame:From Day 1 to Day 113
time to event, event
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame:From Day 1 to Day 113
concentration, descriptive
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
Time frame:From Day 1 to Day 113
concentration, descriptive
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 endpointsSteady State Minimum Concentration (Cmin,ss)
Time frame:From Day 1 to Day 113
concentration, descriptive
Steady State Concentration (Cav,ss)
Time frame:From Day 1 to Day 113
concentration, descriptive
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.