HRS9531 Controls Weight Regain in Obese Subjects

Phase 2Active Not RecruitingNCT06287437

Shanghai Zhongshan Hospital72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

HRS9531DRUG

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

HRS9531 placeboDRUG

HRS9531 placebo low frequency injection for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xiaoying Li

Shanghai, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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