Efficacy and Safety of HRS9531 Tablet in Obese Subjects

NCT06841445 | Active Not Recruiting Phase 2

• 1 other identifier: HRS9531-T-201
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.

Conditions

Chronic Management of Body Weight

Outcome Measures

Primary Outcomes (1)

• Percentage Change from baseline in body weight after 26 weeks of treatment

  after 26 weeks of treatment

Secondary Outcomes (9)

• Proportion of subjects with weight loss of ≥5% from baseline in body weight after 26 weeks of treatment

  after 26 weeks of treatment

• Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment

  after 26 weeks of treatment

• Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment

  after 26 weeks of treatment

• Change from baseline in body weight after 26 weeks of treatment

  after 26 weeks of treatment

• Change from baseline in waist circumference after 26 weeks of treatment

  after 26 weeks of treatment

Study Arms (4)

Treatment group A: HRS9531 Tablet

EXPERIMENTAL

Drug: HRS9531 Tablet

Treatment group B: HRS9531 Tablet

EXPERIMENTAL

Drug: HRS9531 Tablet

Treatment group C: HRS9531 Tablet

EXPERIMENTAL

Drug: HRS9531 Tablet

Treatment group D: HRS9531 Tablet Placebo

PLACEBO COMPARATOR

Drug: HRS9531 Tablet placebo

Interventions

HRS9531 Tablet DRUG

HRS9531 Tablet dose 1

Treatment group A: HRS9531 Tablet

HRS9531 Tablet placebo DRUG

HRS9531 Tablet placebo

Treatment group D: HRS9531 Tablet Placebo

Eligibility Criteria

• Age: 18 Years - 65 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, 18-65 years of age at the time of signing informed consent;
• At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
• Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
• Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

You may not qualify if:

• Uncontrollable hypertension;
• 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;
• PHQ-9 score ≥15;
• Medical history or illness that affects body weight;
• History of diabetes;
• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
• History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• Any organ-system malignancies developed within 5 years;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
• History of alcohol and/or substance abuse or drug abuse;
• Use of any medication or treatment that may have caused significant weight change within 3 months;
• History of bariatric surgery;
• Known or suspected hypersensitivity to trial product(s) or related products;
• 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;

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210008, China

Location

Study Design

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

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: April 7, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CN (1)