Phase 2 Study of MWN109 Tablet for Weight-Loss Maintenance in Participants With Overweight or Obesity
A Multicenter, Randomized, Open-label, Phase 2 Extension Clinical Study Evaluating the Efficacy and Safety of MWN109 Tablets in Weight Loss Maintenance in Non-Diabetic Participants With Overweight or Obesity
Lead sponsor
Asset
MWN109
Oral · GLP-1 / GIP / glucagon triple
Listed sites
1
Recruiting sites
-
Actual enrollment
71
Study population
Obesity / overweight
Eligibility highlights
•BMI ≥18.5
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. Participate in the multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial (MWN109-II-WL) to evaluate the efficacy and safety of MWN109 injection in adult non-diabetic overweight or obese participants in China; complete the EOT visit and safety follow-up of the participants.
2. Participants whose weight decreased by ≥5% compared to baseline at the EOT visit of the MWN109-II-WL study.
3. Participants with a BMI > 18.5 kg/m² at the time of the safety follow-up in the MWN109-II-WL study and at the time of randomization at Visit 2 (V2) of this study, and who were evaluated by the investigator as suitable for participating in this study.
4. Agree not to use other weight-loss drugs or treatments during the study period.
5. From the time of signing the informed consent until 3 months after the last dose of the investigational drug, the participant must have no intention of becoming pregnant and must voluntarily use effective contraceptive measures to prevent pregnancy (or ensure their partner does). There must be no plans for sperm or egg donation. Participants of childbearing potential must not be breastfeeding, and the pregnancy test result prior to randomization must be negative.
Exclusion criteria
1. Previously diagnosed with type 1, type 2, or any other type of diabetes (excluding gestational diabetes).
2. At the EOT visit of the MWN109-II-WL study, the fasting plasma glucose in the central laboratory was ≥ 7.0 mmol/L, or the HbA1c was ≥ 6.5%.
3. At the screening stage, the PHQ-9 questionnaire score was ≥ 15; or at the screening stage, there was a suicidal tendency or suicidal behavior, or the subject was judged to have a suicidal risk.
4. Plans to participate in another clinical study of a trial drug or device before completing all the scheduled assessments in this clinical study, or to take drugs or non-drug treatments that affect weight (excluding diet and exercise control).
Endpoints (9)
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
7 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 from baseline in body weight over time
Time frame:Baseline, Week 24
change from baseline, improvement
The proportion of participants whose weight remained unchanged from baseline to 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 waist-to-hip ratio (WHR) over time
Time frame:up to 24 weeks
change from baseline, improvement
Time to first body weight greater than baseline at two consecutive visits
Time frame:up to 24 weeks
time to event, event
Safety / tolerability / PK
1 endpointIncidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame:up to 24 weeks
event count, event
Other (unclassified)
1 endpointChange from Baseline in IWQOL-Lite-CT Score over time
Time frame:up to 24 weeks
change from baseline, improvement
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.