A Phase 2 interventional study of HRS9531 and HRS9531 placebo in Obesity, sponsored by Shanghai Zhongshan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients
Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531
Drug: HRS9531
The subjects receive low frequency subcutaneous injection of the placebo
Drug: HRS9531 placebo
HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ，then low frequency injection for 12 weeks.
HRS9531 placebo low frequency injection for 12 weeks.
Percent Change in Body Weight from 24 weeks
Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo
Time frame: 36 weeks
Energy intake change from 24 weeks
Differences in energy intake changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Energy expenditure change from 24 weeks
Differences in energy expenditure changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Metabolic adaptation from 24 weeks
Differences in metabolic adaptation changes between the HRS9531 group and the placebo group from week36-week24（Metabolic adaptation=Actual measured resting energy expenditure-Predicted resting energy expenditure. The Actual measured resting energy expenditure will be measured using the Maastricht Instruments Room Calorimeter ADVANCE. The predicted energy expenditure will be fitted by multiple linear regression according to the age, sex, and body composition information of the subjects at baseline.）
Time frame: 24-36 weeks
Systolic blood pressure and diastolic blood pressure change from 24 weeks
Differences in systolic blood pressure and diastolic blood pressure changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Body fat rate change from 24 weeks
Differences in body fat rate changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Serum total cholesterol change from 24 weeks
Differences in Serum total cholesterol changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Triglyceride change from 24 weeks
Differences in Triglyceride changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Nonestesterified fatty acid change from 24 weeks
Differences in nonestesterified fatty acid changes between the HRS9531 group and the placebo group from week36-week24
Time frame: 24-36 weeks
Energy intake at baseline
Differences in energy intake at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.
Time frame: 0 weeks
Energy expenditure at baseline
Differences in energy expenditure at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.
Time frame: 0 weeks
Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale)
Differences in appetite at baseline in obese diabetic subjects, relative to obese non-diabetic subjects (Appetite was assessed using the Visual Analogue Scale subjective rating scale. On a standard scale of 100mm in length, the left end (0mm) means "not at all" and the right end (100mm) means "extremely").
Time frame: 0 weeks
Percent Change in Body Weight at 24 weeks
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in body weight change after once weekly injection of HRS9531
Time frame: 24 weeks
Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in appetite after once weekly injection of HRS9531(Appetite was assessed using the Visual Analogue Scale subjective rating scale. On a standard scale of 100mm in length, the left end (0mm) means "not at all" and the right end (100mm) means "extremely").
Time frame: 24 weeks
Energy expenditure at 24 weeks
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in energy expenditure after once weekly injection of HRS9531
Time frame: 24 weeks
Energy intake at 24 weeks
Obese diabetic subjects, relative to obese non-diabetic subjects, difference in Energy intake after once weekly injection of HRS9531
Time frame: 24 weeks
Change of body weight at 24 weeksl from baseline
Change of body weight from baseline to 24 weeks
Time frame: 24 weeks
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Zhongshan Hospital