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

NCT06250946 | Completed Phase 2

• 1 other identifier: HRS-7535-202
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from baseline at Week 26

  Week 26

Secondary Outcomes (11)

• 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

Study Arms (5)

Group A

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535;Placebo

Group B

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535;Placebo

Group C

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535;Placebo

Group D

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 administered orally

Drug: HRS-7535;Placebo

Group E

PLACEBO COMPARATOR

Subjects will receive Placebo administered orally

Drug: Placebo

Interventions

HRS-7535;Placebo DRUG

HRS-7535;Placebo

Group A; Group B; Group C; Group D

Placebo DRUG

Placebo

Group E

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 23, 2024
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)