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Clinical Trials in China / NCT07804797
Active, not recruiting Phase 2

Phase 2 Study of MWN109 Tablet for Weight-Loss Maintenance in Participants With Overweight or Obesity

NCT07804797 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Minwei Biotechnology Co., Ltd
Phase
Phase 2
Started
2026-03-02
Last updated
2026-09-04

Condition(s) studied

Overweight , Obesity

Investigational drug(s) / intervention(s)

MWN109 1 →MWN109 2 →

MWN109 1: Administered orally, QD, 24 weeks

MWN109 2: Administered orally, QW, 24 weeks

Study summary

This study adopted a randomized, open-label design, aiming to preliminarily explore the weight-loss maintenance effect of MWN109 tablets when administered continuously for 24 weeks in non-diabetic overweight or obese participants.

Participants who met the inclusion criteria were randomly assigned (1:1) to either the QD or QW administration group of MWN109 tablets, with the dose grouping in the MWN109-II-WL study serving as a random stratification factor.

This study included a maximum screening period of 2 weeks, a 24-week treatment observation period, and a 2-week safety follow-up period, totaling 28 weeks. The primary endpoint was the percentage change in weight from baseline after 24 weeks of administration. The secondary endpoints included the change in weight from baseline after 24 weeks of administration, as well as the change in waist circumference from baseline.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Percentage change in body weight compared to baseline after 24 weeks of drug administration — Baseline, Week 24
    Percentage change in body weight from baseline to Week 24.

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Henan University of Science and Technology Luoyang Henan

More Shanghai Minwei Biotechnology Co., Ltd trials in China

Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight Active, not recruiting
Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus Recruiting
Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity Recruiting
Phase 1 Clinical Study of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension Recruiting
Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity Starting soon

Other trials for the same condition

Study of UBT37034 Injection Recruiting
Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight Active, not recruiting
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants Active, not recruiting
Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity Recruiting
Study on the Efficacy of Probiotics in the Treatment of Childhood Obesity and Their Effects on Gut Microbiota Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07804797 on ClinicalTrials.gov ↗ ← All trials in China