Overweight or ObesityPhase 2NCT05881837

A Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

A Phase 2 study testing HRS9531 injection in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 25 sites in China.

Completed

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

Official record

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Trial summary

This study aims to evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Overweight or Obesity
What is being tested?: HRS9531 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 249 participants
Where: 25 sitesChina
Study dates: 13 Jun 2023to 13 Oct 2024
Phase: Phase 2

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 less than 5 kg self-reported change within the last 3 months.

Who cannot join

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 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;

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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 and in-situ cancer of the cervix;
Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
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;
Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
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;
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

China25 sites

Baotou Central Hospital
Baotou, Inner Mongolia, 014040
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The Second Hospital of Jilin University
Changchun, Jilin, 130022
Chengdu Second People's Hospital
Chengdu, Sichuan, 610000
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, 510800
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
The Central Hospital Of Huangshi
Huangshi, Hubei, 435000
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Lianyungang Hospital of TCM
Lianyungang, Jiangsu, 222001
The First People's Hospital Of Lianyungang
Lianyungang, Jiangsu, 222002
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, 471000
Sencond Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004
The People's Hospital of Longhua. Shenzhen
Shenzhen, Guangdong, 518110
Second Hospttoal of Shanxi Medical University
Taiyuan, Shanxi, 030000
The Third People's Hospital of Hubei Province
Wuhan, Hubei, 430000
The First Affiliated Hospital of Xi'an Medical College
Xian, Shanxi, 710000
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 222004
North Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001

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 Injection in Obese Subjects Without Diabetes

Conditions: Overweight or Obesity
Being tested: HRS9531 injection, HRS9531 injection Placebo
Medical subject headings: Overweight, Obesity

What participants receive

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

HRS9531 injectionDrug
HRS9531 injection: dose level 1 for 32 weeks; level 2 for 20 weeks
HRS9531 injectionDrug
HRS9531 injection: dose level 2
HRS9531 injectionDrug
HRS9531 injection: dose level 3
HRS9531 injectionDrug
HRS9531 injection: dose level 4
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks; HRS9531 injection level 2 for 20 weeks
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks; HRS9531 injection level 2 for 20 weeks
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks; HRS9531 injection level 2 for 20 weeks
HRS9531 injection PlaceboDrug
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks; HRS9531 injection level 2 for 20 weeks

Study groups in NCT05881837
Study group	Role	What they receive
Treatment group A	Experimental	HRS9531 injection Receives: Drug: HRS9531 injection
Treatment group B	Experimental	HRS9531 injection Receives: Drug: HRS9531 injection
Treatment group C	Experimental	HRS9531 injection Receives: Drug: HRS9531 injection
Treatment group D	Experimental	HRS9531 injection Receives: Drug: HRS9531 injection
Treatment group E	Placebo comparator	HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo
Treatment group F	Placebo comparator	HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo
Treatment group G	Placebo comparator	HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo
Treatment group H	Placebo comparator	HRS9531 injection Placebo Receives: Drug: HRS9531 injection Placebo

What is being measured

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

Percentage change in body weight
Percentage Change from baseline in body weight after 24 weeks of treatment
Measured: Week 0, Week 24

Secondary outcomes (20)

Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Measured: Week 24
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Measured: Week 24
Change from baseline in body weight after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in waist circumference after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in BMI after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in blood pressure after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in total cholesterol after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Measured: Week 0, Week 24
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Measured: Week 0, Week 24
Number of AEs During the Trial
Measured: Week 0 to Week 56
Percentage change in body weight
Measured: Week 0, Week 32
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
Measured: Week 32
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
Measured: Week 32
Change from baseline in body weight after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in waist circumference after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in BMI after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in blood pressure after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in total cholesterol after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
Measured: Week 0, Week 32
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
Measured: Week 0, Week 32

Timeline

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

13 Jun 202313 Oct 2024

First posted31 May 2023
Study start13 Jun 2023
Primary completion13 Oct 2024
Study completion13 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overweight or ObesityStudies of the same condition, open and under way.
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
Model description: A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05881837
Sponsor's protocol ID: HRS9531-201
Status last verified: Oct 2026
First submitted: 17 May 2023
Last updated: 22 Oct 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?

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