Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes
Trial Parameters
Brief Summary
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged ≥18 years at the time of signing informed consent. 2. BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain. 3. A self-reported change in body weight no more than 5% within 90 days before screening. 4. Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form. Exclusion Criteria: 1. Have type 1 diabetes mellitus (T1DM) or T2DM. 2. Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1. 3. Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine. 4. Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months pri