Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .

Shandong Suncadia Medicine

Status and phase: Completed; Phase 2

Conditions: Overweight and Obesity

Treatments: Drug: HRS-7535;Placebo; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06250946

HRS-7535-202

Details and patient eligibility

About

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

Enrollment: 235 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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235 participants in 5 patient groups, including a placebo group

Group A

Experimental group

Description:

Subjects will receive escalated dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535;Placebo

Group B

Experimental group

Description:

Subjects will receive escalated dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535;Placebo

Group C

Experimental group

Description:

Subjects will receive escalated dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535;Placebo

Group D

Experimental group

Description:

Subjects will receive escalated dose of HRS-7535 administered orally

Treatment:

Drug: HRS-7535;Placebo

Group E

Placebo Comparator group

Description:

Subjects will receive Placebo administered orally

Treatment:

Drug: Placebo