NCT07670884

Brief Summary

This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
675

participants targeted

Target at P75+ for phase_3

Timeline
16mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Nov 2027

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

June 22, 2026

Last Update Submit

July 19, 2026

Conditions

Chronic Management of Body Weight

Outcome Measures

Primary Outcomes (2)

  • Percentage change from baseline in body weight after 52 weeks of treatment

    After 52 weeks of treatment.

  • Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment

    After 52 weeks of treatment.

Secondary Outcomes (14)

  • Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment

    After 52 weeks of treatment.

  • Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment

    After 52 weeks of treatment.

  • Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment

    After 52 weeks of treatment.

  • Change from baseline in waist circumference after 52 weeks of treatment

    After 52 weeks of treatment.

  • Change from baseline in body weight after 52 weeks of treatment

    After 52 weeks of treatment.

  • +9 more secondary outcomes

Study Arms (2)

HRS9531 Tablet Group

EXPERIMENTAL

HRS9531 tablet.

Drug: HRS9531 Tablet

HRS9531 Tablet Placebo Group

PLACEBO COMPARATOR

HRS9531 tablet placebo.

Drug: HRS9531 Tablet Placebo

Interventions

HRS9531 TabletDRUG

HRS9531 tablet.

HRS9531 Tablet Group
HRS9531 Tablet PlaceboDRUG

HRS9531 tablet placebo.

HRS9531 Tablet Placebo Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, 18-75 years of age at the time of signing informed consent;
  • At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
  • 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;
  • 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 severe hypertension;
  • PHQ-9 score ≥ 15;
  • Medical history or illness that affects body weight;
  • History of diabetes;
  • Acute or chronic hepatitis;
  • History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
  • Any organ-system malignancies developed within 5 years;
  • Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
  • Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
  • Use of any medication or treatment that may have caused significant weight change within 90 days;
  • History of bariatric surgery;
  • Known or suspected hypersensitivity to trial product(s) or related products;
  • History of alcohol and/or substance abuse or drug abuse;
  • History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Central Study Contacts

Danli Zhang, M.M

CONTACT

+86-0518-82342973danli.zhang@hengrui.com

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
Model Details: HRS9531 tablets compared with placebo.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

July 17, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations

CN(2)