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

Shanghai Zhongshan Hospital1 site in 1 country72 target enrollmentJanuary 1, 2024

ConditionsObesity

InterventionsHRS9531 HRS9531 placebo

DrugsHRS9531 HRS9531 placebo

Overview

Phase: Phase 2
Intervention: HRS9531
Conditions: Obesity
Sponsor: Shanghai Zhongshan Hospital
Enrollment: 72
Locations: 1
Primary Endpoint: Percent Change in Body Weight from 24 weeks
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 1, 2024

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Zhongshan Hospital

Responsible Party

Principal Investigator

Xiaoying Li

Study Principal Investigator

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

•30-60 years old, female and male.
•BMI:30-40kg/m
•Non diabetes or type 2 diabetes with HbA1c between 7-10%.

Exclusion Criteria

•Weight change ≤5 kg within 3 months.
•Hb\<110g/L.
•Serum triglycerides 5.7 mmol/L.
•Impaired liver function ：ALT or AST≥3×ULN，TB≥2×ULN.
•Impaired renal function：eGFT \< 45 ml/min.
•Hemodiastase or Serum lipase≥3×ULN.
•TSH\>6.0 mIU/L or\<0.4 mIU/L.
•Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
•lth Questionnaire-9 (PHQ-9) score ≥
•Type 1 diabetes.

Arms & Interventions

Intervention

The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531

Intervention: HRS9531

Control

The subjects receive low frequency subcutaneous injection of the placebo

Intervention: HRS9531 placebo

Outcomes

Primary Outcomes

Percent Change in Body Weight from 24 weeks

Time Frame: 36 weeks

Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo

Secondary Outcomes

Energy intake change from 24 weeks(24-36 weeks)
Energy expenditure change from 24 weeks(24-36 weeks)
Metabolic adaptation from 24 weeks(24-36 weeks)
Systolic blood pressure and diastolic blood pressure change from 24 weeks(24-36 weeks)
Body fat rate change from 24 weeks(24-36 weeks)
Serum total cholesterol change from 24 weeks(24-36 weeks)
Triglyceride change from 24 weeks(24-36 weeks)
Nonestesterified fatty acid change from 24 weeks(24-36 weeks)
Energy intake at baseline(0 weeks)
Energy expenditure at baseline(0 weeks)
Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale)(0 weeks)
Percent Change in Body Weight at 24 weeks(24 weeks)
Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)(24 weeks)
Energy expenditure at 24 weeks(24 weeks)
Energy intake at 24 weeks(24 weeks)