About this trial
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.
Eligibility criteria
Qualifiers
Able and willing to provide a written informed consent.
Male or female adults aged 18 to 65 years.
BMI: 28.0 to 40.0 kg/m2.
Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.
Disqualifiers
Endocrine disease or history that may have a significant effect on body weight;
History of diabetes mellitus (gestational diabetes excepted);
Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;
Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;
Trial design
Treatments tested in this trial
- HRS-4729 Injection
- HRS-4729 Injection
- HRS-4729 Injection
- HRS-4729 Injection;
- HRS-4729 Injection;
- HRS-4729 Injection;
- HRS-4729 Injection Placebo
Treatment groups
7
Treatment groupsSee each treatment group below.