A Phase 2 interventional study of MWN109 1 and MWN109 2 in Overweight , Obesity, sponsored by Shanghai Minwei Biotechnology Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Shanghai Minwei Biotechnology Co., Ltd · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: MWN109 1
Drug: MWN109 2
Administered orally, QD, 24 weeks
Administered orally, QW, 24 weeks
Percentage change in body weight compared to baseline after 24 weeks of drug administration
Percentage change in body weight from baseline to Week 24.
Time frame: Baseline, Week 24
Change from baseline in body weight over time
Change in body weight from baseline to week 24.
Time frame: Baseline, Week 24
The proportion of participants whose weight remained unchanged from baseline to week 24
Proportion of participants with body weight unchanged from baseline at week 24.
Time frame: Baseline, Week 24
Change from baseline in waist circumference over time
Change in waist circumference from baseline to week 24.
Time frame: up to 24 weeks
Change from baseline in body mass index (BMI) over time
Change in BMI from baseline throughout the study.
Time frame: up to 24 weeks
Change from baseline in waist-to-hip ratio (WHR) over time
Change in WHR from baseline throughout the study.
Time frame: up to 24 weeks
Time to first body weight greater than baseline at two consecutive visits
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).
Time frame: up to 24 weeks
Change from Baseline in IWQOL-Lite-CT Score over time
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.
Time frame: up to 24 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants with treatment-emergent adverse events throughout the study.
Time frame: up to 24 weeks
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Minwei Biotechnology Co., Ltd