Clinical trial NCT06841445: Efficacy and Safety of HRS9531 Tablet in Obese Subjects
Official title: A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Tablet in Obese Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Management of Body Weight
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

Exclusion Criteria:

1. Uncontrollable hypertension;
2. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects body weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
15. Surgery is planned during the trial;
16. Mentally incapacitated or speech-impaired;
17. Acute or chronic hepatitis;
18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Primary outcomes:
measure: Percentage Change from baseline in body weight after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
Secondary outcomes:
measure: Proportion of subjects with weight loss of ≥5% from baseline in body weight after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Change from baseline in body weight after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Change from baseline in waist circumference after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Change from baseline in BMI after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Change from baseline in blood pressure after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Change from baseline in blood lipid after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
measure: Change from baseline in blood uric acid after 26 weeks of treatment
timeFrame: after 26 weeks of treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower hospital
state: Jiangsu
Study officials:
References: