To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

NCT06396429 | Completed Phase 3

• 1 other identifier: HRS9531-301
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage change from baseline in weight after 48 weeks of treatment

  Baseline, Week 48

• Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment

  Week 48

Secondary Outcomes (16)

• Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment

  Week 48

• Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment

  Week 48

• Change from baseline in waist circumference after 48 weeks of treatment

  Baseline, Week 48

• Change from baseline in weight after 48 weeks of treatment

  Baseline, Week 48

• Change from baseline in BMI after 48 weeks of treatment

  Baseline, Week 48

Study Arms (4)

Treatment group A: HRS9531 injection

EXPERIMENTAL

Drug: HRS9531 injection

Treatment group B: HRS9531 injection

EXPERIMENTAL

Drug: HRS9531 injection

Treatment group C: HRS9531 injection

EXPERIMENTAL

Drug: HRS9531 injection

Placebo injection

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS9531 injection DRUG

HRS9531 injection; low dose

Treatment group A: HRS9531 injection

Placebo DRUG

blank preparation, participants received matching placebo.

Placebo injection

Eligibility Criteria

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

You may qualify if:

• Able and willing to provide a written informed consent.
• Male or female subjects, ≥18 years of age at the time of signing informed consent.
• At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
• Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
• Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.

You may not qualify if:

• Presence of clinically significant lab results at screening visit;
• Uncontrollable hypertension;
• PHQ-9 score ≥15;
• Medical history or illness that affects your weight;
• History of diabetes;
• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
• 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、 in-situ cancer of the cervix and in-situ cancer of the prostate;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
• Known or suspected history of alcohol and/or substance abuse or drug abuse;
• History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
• Have received or plan to have an organ or bone marrow transplant during the study.
• The presence of any blood disorders that may interfere with HbA1c testing.
• Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
• Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, 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

Model Details: Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: May 13, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)