Overweight , Obesity
Conditions
Brief 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.
Interventions
Sponsors
Shanghai Minwei Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body weight over time | Baseline, Week 24 | Change in body weight from baseline to week 24. |
| The proportion of participants whose weight remained unchanged from baseline to week 24 | Baseline, Week 24 | Proportion of participants with body weight unchanged from baseline at week 24. |
| Change from baseline in waist circumference over time | up to 24 weeks | Change in waist circumference from baseline to week 24. |
| Change from baseline in body mass index (BMI) over time | up to 24 weeks | Change in BMI from baseline throughout the study. |
| Change from baseline in waist-to-hip ratio (WHR) over time | up to 24 weeks | Change in WHR from baseline throughout the study. |
| Time to first body weight greater than baseline at two consecutive visits | 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). |
| Change from Baseline in IWQOL-Lite-CT Score over time | 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. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | up to 24 weeks | Number and proportion of participants with treatment-emergent adverse events throughout the study. |
Countries
China
Outcome results
None listed