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Active, not recruiting

NCT Number: NCT07804797

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Overweight , Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Participants whose weight decreased by ≥5% compared to baseline at the EOT visit of the MWN109-II-WL study.
  • 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.
  • Agree not to use other weight-loss drugs or treatments during the study period.
  • 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

  • Previously diagnosed with type 1, type 2, or any other type of diabetes (excluding gestational diabetes).
  • 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%.
  • 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.
  • 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).

Treatment and study plan

MWN109 1

Drug

Administered orally, QD, 24 weeks

MWN109 2

Drug

Administered orally, QW, 24 weeks

Primary outcomes

  1. Percentage change in body weight compared to baseline after 24 weeks of drug administration

    Time frame: Baseline, Week 24

    Percentage change in body weight from baseline to Week 24.

Secondary outcomes

  1. Change from baseline in body weight over time

    Time frame: Baseline, Week 24

    Change in body weight from baseline to week 24.

  2. The proportion of participants whose weight remained unchanged from baseline to week 24

    Time frame: Baseline, Week 24

    Proportion of participants with body weight unchanged from baseline at week 24.

  3. Change from baseline in waist circumference over time

    Time frame: up to 24 weeks

    Change in waist circumference from baseline to week 24.

  4. Change from baseline in body mass index (BMI) over time

    Time frame: up to 24 weeks

    Change in BMI from baseline throughout the study.

  5. Change from baseline in waist-to-hip ratio (WHR) over time

    Time frame: up to 24 weeks

    Change in WHR from baseline throughout the study.

  6. Time to first body weight greater than baseline at two consecutive visits

    Time frame: up to 24 weeks

    Time to the first occurrence of body weight greater than the baseline level at two consecutive visits (calculated based on the time of the second visit).

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

    Time frame: up to 24 weeks

    The IWQOL-Lite-CT, a 20-item patient-reported outcome (PRO) tool, evaluates weight-related physical and psychosocial function. Each of its 5 response choices (A-E) yields a score from 1 to 5. Total scores range from 20 to 100. Higher composite and total scores indicate better functional status of the participants.

  8. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: up to 24 weeks

    Number and proportion of participants with treatment-emergent adverse events throughout the study.

Sponsors and collaborators

Lead sponsor

Shanghai Minwei Biotechnology Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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