Chronic Management of Body WeightPhase 2NCT06841445

Efficacy and Safety of HRS9531 Tablet in Obese Subjects

A Phase 2 study testing HRS9531 Tablet in people with Chronic Management of Body Weight, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Management of Body Weight
What is being tested?: HRS9531 Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 166 participants
Where: 1 siteChina
Study dates: 7 Apr 2025to 8 Jan 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 18Show fewer

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;
Mentally incapacitated or speech-impaired;
Acute or chronic hepatitis;
The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Tablet in Obese Subjects

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
Being tested: HRS9531 Tablet, HRS9531 Tablet placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS9531 TabletDrug
HRS9531 Tablet dose 1
HRS9531 TabletDrug
HRS9531 Tablet dose 2
HRS9531 TabletDrug
HRS9531 Tablet dose 3
HRS9531 Tablet placeboDrug
HRS9531 Tablet placebo

Study groups in NCT06841445
Study group	Role	What they receive
Treatment group A: HRS9531 Tablet	Experimental	Not described Receives: Drug: HRS9531 Tablet
Treatment group B: HRS9531 Tablet	Experimental	Not described Receives: Drug: HRS9531 Tablet
Treatment group C: HRS9531 Tablet	Experimental	Not described Receives: Drug: HRS9531 Tablet
Treatment group D: HRS9531 Tablet Placebo	Placebo comparator	Not described Receives: Drug: HRS9531 Tablet placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change from baseline in body weight after 26 weeks of treatment
Measured: 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
Measured: after 26 weeks of treatment
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment
Measured: after 26 weeks of treatment
Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment
Measured: after 26 weeks of treatment
Change from baseline in body weight after 26 weeks of treatment
Measured: after 26 weeks of treatment
Change from baseline in waist circumference after 26 weeks of treatment
Measured: after 26 weeks of treatment
Change from baseline in BMI after 26 weeks of treatment
Measured: after 26 weeks of treatment
Change from baseline in blood pressure after 26 weeks of treatment
Measured: after 26 weeks of treatment
Change from baseline in blood lipid after 26 weeks of treatment
Measured: after 26 weeks of treatment
Change from baseline in blood uric acid after 26 weeks of treatment
Measured: after 26 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 20258 Jan 2026

First posted24 Feb 2025
Study start7 Apr 2025
Primary completion8 Jan 2026
Study completion8 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Management of Body WeightStudies of the same condition, open and under way.
More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06841445
Sponsor's protocol ID: HRS9531-T-201
Status last verified: Mar 2026
First submitted: 18 Feb 2025
Last updated: 3 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight

All Chronic Management of Body Weight trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Tablet in Obese Subjects
ClinicalTrials.gov ID: NCT06841445
Acronym / sponsor ID: HRS9531-T-201
Conditions: Chronic Management of Body Weight
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Apr 2025 (actual)
Primary completion: 8 Jan 2026 (actual)
Study completion: 8 Jan 2026 (actual)
First posted: 24 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS9531 TabletHRS9531 Tablet dose 1	Drug	Treatment group A: HRS9531 Tablet
HRS9531 TabletHRS9531 Tablet dose 2	Drug	Treatment group B: HRS9531 Tablet
HRS9531 TabletHRS9531 Tablet dose 3	Drug	Treatment group C: HRS9531 Tablet
HRS9531 Tablet placeboHRS9531 Tablet placebo	Drug	Treatment group D: HRS9531 Tablet Placebo

Primary outcome

Percentage Change from baseline in body weight after 26 weeks of treatment
Time frame: after 26 weeks of treatment

9 secondary outcomes

Proportion of subjects with weight loss of ≥5% from baseline in body weight after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Change from baseline in body weight after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Change from baseline in waist circumference after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Change from baseline in BMI after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Change from baseline in blood pressure after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Change from baseline in blood lipid after 26 weeks of treatment
Time frame: after 26 weeks of treatment
Change from baseline in blood uric acid after 26 weeks of treatment
Time frame: after 26 weeks of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Management of Body Weight

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS9531 Tablet in people with Chronic Management of Body Weight, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change from baseline in body weight after 26 weeks of treatment (time frame: after 26 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06841445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.