HRS9531 Controls Weight Regain in Obese Subjects

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: HRS9531; Drug: HRS9531 placebo

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Xiaoying Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531	Drug: HRS9531; HRS9531 escalated to the protocol-specified dose once weekly injection for 24 weeks ，then low frequency injection for 12 weeks.
Placebo Comparator: Control; The subjects receive low frequency subcutaneous injection of the placebo	Drug: HRS9531 placebo; HRS9531 placebo low frequency injection for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Triglyceride change from 24 weeks	Differences in Triglyceride changes between the HRS9531 group and the placebo group from week36-week24	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	24-36 weeks
Energy intake at baseline	Differences in energy intake at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.	0 weeks
Energy expenditure at baseline	Differences in energy expenditure at baseline in obese diabetic subjects, relative to obese non-diabetic subjects.	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").	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	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").	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	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	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body weight at 24 weeksl from baseline	Change of body weight from baseline to 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xiaoying Li, MD, Zhongshan Hosptial, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: B2023-335R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No