Clinical trial NCT06287437: HRS9531 Controls Weight Regain in Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Body Weight from 24 weeks
timeFrame: 36 weeks
Secondary outcomes:
measure: Energy intake change from 24 weeks
timeFrame: 24-36 weeks
measure: Energy expenditure change from 24 weeks
timeFrame: 24-36 weeks
measure: Metabolic adaptation from 24 weeks
timeFrame: 24-36 weeks
measure: Systolic blood pressure and diastolic blood pressure change from 24 weeks
timeFrame: 24-36 weeks
measure: Body fat rate change from 24 weeks
timeFrame: 24-36 weeks
measure: Serum total cholesterol change from 24 weeks
timeFrame: 24-36 weeks
measure: Triglyceride change from 24 weeks
timeFrame: 24-36 weeks
measure: Nonestesterified fatty acid change from 24 weeks
timeFrame: 24-36 weeks
measure: Energy intake at baseline
timeFrame: 0 weeks
measure: Energy expenditure at baseline
timeFrame: 0 weeks
measure: Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale)
timeFrame: 0 weeks
measure: Percent Change in Body Weight at 24 weeks
timeFrame: 24 weeks
measure: Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)
timeFrame: 24 weeks
measure: Energy expenditure at 24 weeks
timeFrame: 24 weeks
measure: Energy intake at 24 weeks
timeFrame: 24 weeks
Other outcomes:
measure: Change of body weight at 24 weeksl from baseline
timeFrame: 24 weeks
Locations:
city: Shanghai
country: China
facility: Xiaoying Li
Study officials:
affiliation: Zhongshan Hosptial, Fudan University
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
References: