Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shanghai Minwei Biotechnology Co., Ltd
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
