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Active not recruitingPhase 2

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

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

NCT IDNCT07804797
Org study IDMWN109-Oral-II-MTN

Timeline

Milestones

Study start2026-03-02actual
Study first posted2026-09-04actual
Last update posted2026-09-04actual
Primary completion2026-09estimated (month precision)
Study completion2026-09estimated (month precision)

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. 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
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

7 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 from baseline in body weight over time

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

The proportion of participants whose weight remained unchanged from baseline to 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 waist-to-hip ratio (WHR) over time

Time frame:up to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:up to 24 weeks

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from Baseline in IWQOL-Lite-CT Score over time

Time frame:up to 24 weeks

change from baseline, improvement

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.