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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
825
Initiate 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.
Initiate 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.
Initiate 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.
Zhongshan Hoapital
Shanghai, China
RECRUITINGprimary outcome
The percentage change in body weight from baseline to week 40
Time frame: week 40
Co-primary outcome
Proportion of subjects with body weight reduction ≥ 5% at Week 40.
Time frame: week 40
secondary outcome
The proportion of participants reaching a body weight loss of at least 10% and 15% at week 40
Time frame: week 40
secondary outcome
Change in waist circumference, body weight and BMI at week 40
Time frame: week 40
secondary outcome
Change in waist circumference, body weight and BMI at week 52
Time frame: week 52
secondary outcome
Change in systolic blood pressure (SBP), diastolic blood pressure (DBP) and lipids at week 40
Time frame: week 40
secondary outcome
Change in SBP, DBP and lipids at week 52
Time frame: week 52
safety outcome
the incidence of adverse events
Time frame: week 52
patient report outcome
36-Item Short Form Health Survey, Version 2 questionnaire (scores range from 0 to 100, with higher scores indicating better health status) after administration for 52 weeks.
Time frame: week 52
Immunogenicity outcome
ADA and NAb
Time frame: week 52
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