HRS9531 Controls Weight Regain in Obese Subjects

Phase 2

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: HRS9531; Drug: HRS9531 placebo

• Registration Number: NCT06287437
• Lead Sponsor: Shanghai Zhongshan Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-01-02
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	HRS9531	The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531
Control	HRS9531 placebo	The subjects receive low frequency subcutaneous injection of the placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Xiaoying Li; 🇨🇳 Shanghai, China