Clinical trial NCT06250946: Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight and Obesity
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 235
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: OTHER

Brief summary: The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, 18-65 years of age at the time of signing informed consent;
2. At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
3. Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
4. Able and willing to provide a written informed consent

Exclusion Criteria:

1. 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;
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. History of diabetes;
5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
6. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
7. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
8. Use of any medication or treatment that may have caused significant weight change within 2 months;
9. History of bariatric surgery;
10. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
11. Surgery is planned during the trial;
12. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
13. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Primary outcomes:
measure: Percent change in body weight from baseline at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Percent change in body weight from baseline at Week 36
timeFrame: Week 36
measure: Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in fasting plasma glucoseat Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in fasting serum insulin at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in HbA1c at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in total cholesterol (TC) at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36
timeFrame: Week 26 and Week 36
measure: Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3
timeFrame: Week 26 and Week 3
measure: Change from baseline in triglycerides (TG) at Week 26 and Week 36
timeFrame: Week 26 and Week 36
Other outcomes:
Locations:
city: Beijing
country: China
facility: The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital
state: Beijing
Study officials:
References: