HRS9531 Controls Weight Regain in Obese Subjects

Fudan University

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity

Treatments: Drug: HRS9531 placebo; Drug: HRS9531

Study type: Interventional

Funder types: Other

Identifiers

NCT06287437

B2023-335R

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Drug: HRS9531

Control

Placebo Comparator group

Description:

The subjects receive low frequency subcutaneous injection of the placebo

Treatment:

Drug: HRS9531 placebo