Obesity
Conditions
Brief summary
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
Interventions
DRUGHRS9531
HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ，then low frequency injection for 12 weeks.
DRUGHRS9531 placebo
HRS9531 placebo low frequency injection for 12 weeks.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 30-60 years old, female and male. 2. BMI:30-40kg/m2. 3. Non diabetes or type 2 diabetes with HbA1c between 7-10%.
Exclusion criteria
1. Weight change ≤5 kg within 3 months. 2. Hb\<110g/L. 3. Serum triglycerides 5.7 mmol/L. 4. Impaired liver function ：ALT or AST≥3×ULN，TB≥2×ULN. 5. Impaired renal function：eGFT \< 45 ml/min. 6. Hemodiastase or Serum lipase≥3×ULN. 7. TSH\>6.0 mIU/L or\<0.4 mIU/L. 8. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. 9. lth Questionnaire-9 (PHQ-9) score ≥15. 10. Type 1 diabetes. 11. Proliferative diabetic retinopathy, ketoacidosis or hyperglycemia hypertonic state within 3 months. 12. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Body Weight from 24 weeks | 36 weeks | Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy intake change from 24 weeks | 24-36 weeks | Differences in energy intake changes between the HRS9531 group and the placebo group from week36-week24 |
| Energy expenditure change from 24 weeks | 24-36 weeks | Differences in energy expenditure changes between the HRS9531 group and the placebo group from week36-week24 |
| Metabolic adaptation from 24 weeks | 24-36 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.） |
| Systolic blood pressure and diastolic blood pressure change from 24 weeks | 24-36 weeks | Differences in systolic blood pressure and diastolic blood pressure changes between the HRS9531 group and the placebo group from week36-week24 |
| Body fat rate change from 24 weeks | 24-36 weeks | Differences in body fat rate changes between the HRS9531 group and the placebo group from week36-week24 |
| Serum total cholesterol change from 24 weeks | 24-36 weeks | Differences in Serum total cholesterol changes between the HRS9531 group and the placebo group from week36-week24 |
| Triglyceride change from 24 weeks | 24-36 weeks | Differences in Triglyceride changes between the HRS9531 group and the placebo group from week36-week24 |
| Energy intake at baseline | 0 weeks | Differences in energy intake at baseline in obese diabetic subjects, relative to obese non-diabetic subjects. |
| Energy expenditure at baseline | 0 weeks | Differences in energy expenditure at baseline in obese diabetic subjects, relative to obese non-diabetic subjects. |
| Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale) | 0 weeks | 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). |
| Percent Change in Body Weight at 24 weeks | 24 weeks | Obese diabetic subjects, relative to obese non-diabetic subjects, difference in body weight change after once weekly injection of HRS9531 |
| Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale) | 24 weeks | 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). |
| Energy expenditure at 24 weeks | 24 weeks | Obese diabetic subjects, relative to obese non-diabetic subjects, difference in energy expenditure after once weekly injection of HRS9531 |
| Energy intake at 24 weeks | 24 weeks | Obese diabetic subjects, relative to obese non-diabetic subjects, difference in Energy intake after once weekly injection of HRS9531 |
| Nonestesterified fatty acid change from 24 weeks | 24-36 weeks | Differences in nonestesterified fatty acid changes between the HRS9531 group and the placebo group from week36-week24 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of body weight at 24 weeksl from baseline | 24 weeks | Change of body weight from baseline to 24 weeks |
Countries
China
Outcome results
None listed