NCT06250946CompletedPhase 2
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects
Shandong Suncadia Medicine Co., Ltd.1 site in 1 country235 target enrollmentStarted: February 23, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 235
- Locations
- 1
- Primary Endpoint
- Percent change in body weight from baseline at Week 26
Study Overview
Brief Summary
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects, 18-65 years of age at the time of signing informed consent;
- •At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
- •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.
- •Able and willing to provide a written informed consent
Exclusion Criteria
- •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;
- •Uncontrollable hypertension;
- •PHQ-9 score ≥15;
- •History of diabetes;
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •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;
- •Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- •Use of any medication or treatment that may have caused significant weight change within 2 months;
- •History of bariatric surgery;
- •history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- •Surgery is planned during the trial;
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
- •Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
Arms & Interventions
Group B
Experimental
Subjects will receive escalated dose of HRS-7535 administered orally
Intervention: HRS-7535;Placebo (Drug)
Group A
Experimental
Subjects will receive escalated dose of HRS-7535 administered orally
Intervention: HRS-7535;Placebo (Drug)
Group C
Experimental
Subjects will receive escalated dose of HRS-7535 administered orally
Intervention: HRS-7535;Placebo (Drug)
Group D
Experimental
Subjects will receive escalated dose of HRS-7535 administered orally
Intervention: HRS-7535;Placebo (Drug)
Group E
Placebo Comparator
Subjects will receive Placebo administered orally
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent change in body weight from baseline at Week 26
Time Frame: Week 26
Secondary Outcomes
- Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3(Week 26 and Week 3)
- Change from baseline in triglycerides (TG) at Week 26 and Week 36(Week 26 and Week 36)
- Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36(Week 26 and Week 36)
- Percent change in body weight from baseline at Week 36(Week 36)
- Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36(Week 26 and Week 36)
- Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36(Week 26 and Week 36)
- Change from baseline in fasting plasma glucoseat Week 26 and Week 36(Week 26 and Week 36)
- Change from baseline in fasting serum insulin at Week 26 and Week 36(Week 26 and Week 36)
- Change from baseline in HbA1c at Week 26 and Week 36(Week 26 and Week 36)
- Change from baseline in total cholesterol (TC) at Week 26 and Week 36(Week 26 and Week 36)
- Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36(Week 26 and Week 36)
Investigators
Study Sites (1)
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