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.
Male or female, aged ≥18 years at the time of signing informed consent.
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.
A self-reported change in body weight no more than 5% within 90 days before screening.
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.
Have type 1 diabetes mellitus (T1DM) or T2DM.
Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
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 prior to screening.
Parallel
HDM1005 1
DrugInitiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.
HDM1005 2
DrugInitiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
Placebo
DrugInitiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
primary outcome
The percentage change in body weight from baseline to week 40
Co-primary outcome
Proportion of subjects with body weight reduction ≥ 5% at Week 40.
secondary outcome
The proportion of participants reaching a body weight loss of at least 10% and 15% at week 40
secondary outcome
Change in waist circumference, body weight and BMI at week 40
secondary outcome
Change in waist circumference, body weight and BMI at week 52
secondary outcome
Change in systolic blood pressure (SBP), diastolic blood pressure (DBP) and lipids at week 40
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