HRS9531 Controls Weight Regain in Obese Subjects

Obesity Clinical Trial

Official title:

A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06287437
• Other study ID #: B2023-335R
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• HRS9531
HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ,then low frequency injection for 12 weeks.
• HRS9531 placebo
HRS9531 placebo low frequency injection for 12 weeks.

Locations

Country	Name	City	State
China	Xiaoying Li	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of body weight at 24 weeksl from baseline	Change of body weight from baseline to 24 weeks	24 weeks
Primary	Percent Change in Body Weight from 24 weeks	Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo	36 weeks
Secondary	Energy intake change from 24 weeks	Differences in energy intake changes between the HRS9531 group and the placebo group from week36-week24	24-36 weeks
Secondary	Energy expenditure change from 24 weeks	Differences in energy expenditure changes between the HRS9531 group and the placebo group from week36-week24	24-36 weeks
Secondary	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.)	24-36 weeks
Secondary	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	24-36 weeks
Secondary	Body fat rate change from 24 weeks	Differences in body fat rate changes between the HRS9531 group and the placebo group from week36-week24	24-36 weeks
Secondary	Serum total cholesterol change from 24 weeks	Differences in Serum total cholesterol changes between the HRS9531 group and the placebo group from week36-week24	24-36 weeks
Secondary	Triglyceride change from 24 weeks	Differences in Triglyceride changes between the HRS9531 group and the placebo group from week36-week24	24-36 weeks
Secondary	Nonestesterified fatty acid change from 24 weeks	Differences in nonestesterified fatty acid changes between the HRS9531 group and the placebo group from week36-week24	24-36 weeks
Secondary	Energy intake at baseline	Differences in energy intake at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.	0 weeks
Secondary	Energy expenditure at baseline	Differences in energy expenditure at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.	0 weeks
Secondary	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").	0 weeks
Secondary	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	24 weeks
Secondary	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").	24 weeks
Secondary	Energy expenditure at 24 weeks	Obese diabetic subjects, relative to obese non-diabetic subjects, difference in energy expenditure after once weekly injection of HRS9531	24 weeks
Secondary	Energy intake at 24 weeks	Obese diabetic subjects, relative to obese non-diabetic subjects, difference in Energy intake after once weekly injection of HRS9531	24 weeks