HRS9531 Controls Weight Regain in Obese Subjects

NCT06287437 | Active Not Recruiting Phase 2

• 1 other identifier: B2023-335R
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Other Outcomes (1)

• Change of body weight at 24 weeksl from baseline

  24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: HRS9531

Control

PLACEBO COMPARATOR

The subjects receive low frequency subcutaneous injection of the placebo

Drug: HRS9531 placebo

Interventions

HRS9531 DRUG

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

Intervention

HRS9531 placebo DRUG

HRS9531 placebo low frequency injection for 12 weeks.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old, female and male.
• BMI:30-40kg/m2.
• Non diabetes or type 2 diabetes with HbA1c between 7-10%.

You may not qualify if:

• 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 ≥15.
• Type 1 diabetes.
• Proliferative diabetic retinopathy, ketoacidosis or hyperglycemia hypertonic state within 3 months.
• In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Xiaoying Li

Shanghai, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoying Li, MD

  Zhongshan Hosptial, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: March 1, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)