A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

NCT06904105 | Active Not Recruiting Phase 3

• 1 other identifier: HRS-7535-303
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• The percentage change in body weight relative to the baseline.

  The 50th week after administration.

• The proportion of participants with a body weight reduction of ≥ 5% relative to the baseline.

  The 50th week after administration.

Secondary Outcomes (2)

• The proportion of participants with a body weight reduction of ≥ 10% relative to the baseline.

  The 50th week after administration.

• Adverse events (AEs).

  About 52 weeks.

Study Arms (2)

HRS-7535 Group

EXPERIMENTAL

Drug: HRS-7535 Tablets

HRS-7535 Placebo Group

PLACEBO COMPARATOR

Drug: HRS-7535 Placebo Tablets

Interventions

HRS-7535 Tablets DRUG

HRS-7535 tablets.

HRS-7535 Group

HRS-7535 Placebo Tablets DRUG

HRS-7535 placebo tablets.

HRS-7535 Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On the day of signing the informed consent form, the age should be between 18 and 75 years old.
• At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
• The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
• Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.

You may not qualify if:

• At the screening period, relevant laboratory test results are abnormal.
• Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
• Uncontrolled severe hypertension at the screening period.
• Presence of endocrine diseases that may significantly affect the body weight.
• History of acute or chronic pancreatitis.
• History of significant gastrointestinal diseases.
• Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
• Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
• Known or suspected abuse of alcohol or narcotics.
• Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Chinese 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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 9, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CN (1)