Overweight and ObesityPhase 2NCT06250946

Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .

A Phase 2 study of Overweight and Obesity, run by Shandong Suncadia Medicine 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.

Trial summary

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Overweight and Obesity
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 235 participants
Where: 1 siteChina
Study dates: 23 Feb 2024to 22 Jan 2025
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

Male or female subjects, 18-65 years of age at the time of signing informed consent;
At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
Able and willing to provide a written informed consent

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;
History of diabetes;
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;

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Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
Use of any medication or treatment that may have caused significant weight change within 2 months;
History of bariatric surgery;
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;
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

1 site in 1 country.

China1 site

The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100039

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.

Conditions: Overweight and Obesity
Being tested: HRS-7535;Placebo, 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.

HRS-7535;PlaceboDrug
HRS-7535;Placebo
PlaceboDrug
Placebo

Study groups in NCT06250946
Study group	Role	What they receive
Group A	Experimental	Subjects will receive escalated dose of HRS-7535 administered orally Receives: Drug: HRS-7535;Placebo
Group B	Experimental	Subjects will receive escalated dose of HRS-7535 administered orally Receives: Drug: HRS-7535;Placebo
Group C	Experimental	Subjects will receive escalated dose of HRS-7535 administered orally Receives: Drug: HRS-7535;Placebo
Group D	Experimental	Subjects will receive escalated dose of HRS-7535 administered orally Receives: Drug: HRS-7535;Placebo
Group E	Placebo comparator	Subjects will receive Placebo administered orally Receives: Drug: Placebo

What is being measured

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

Percent change in body weight from baseline at Week 26
Measured: Week 26

Secondary outcomes (11)

Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36
Measured: Week 26 and Week 36
Percent change in body weight from baseline at Week 36
Measured: Week 36
Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in fasting plasma glucoseat Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in fasting serum insulin at Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in HbA1c at Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in total cholesterol (TC) at Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36
Measured: Week 26 and Week 36
Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3
Measured: Week 26 and Week 3
Change from baseline in triglycerides (TG) at Week 26 and Week 36
Measured: Week 26 and Week 36

Timeline

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

23 Feb 202422 Jan 2025

First posted9 Feb 2024
Study start23 Feb 2024
Primary completion22 Jan 2025
Study completion22 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
More trials run by Shandong Suncadia Medicine 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06250946
Sponsor's protocol ID: HRS-7535-202
Status last verified: Apr 2025
First submitted: 1 Feb 2024
Last updated: 13 Apr 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Gu W, Zhang L, Li L, Wei D, Li Q, Zong Y, Ye Z, Shu C, Zhong T, Mu Y. HRS-7535, an oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity without diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Commun. 2026 Jun 22;17(1):7867. doi: 10.1038/s41467-026-73018-y.
PubMed 42331800

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

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects
ClinicalTrials.gov ID: NCT06250946
Acronym / sponsor ID: HRS-7535-202
Conditions: Overweight and Obesity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 Feb 2024 (actual)
Primary completion: 22 Jan 2025 (actual)
Study completion: 22 Jan 2025 (actual)
First posted: 9 Feb 2024 (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.

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group A	Experimental	Drug: HRS-7535;PlaceboSubjects will receive escalated dose of HRS-7535 administered orally
Group B	Experimental	Drug: HRS-7535;PlaceboSubjects will receive escalated dose of HRS-7535 administered orally
Group C	Experimental	Drug: HRS-7535;PlaceboSubjects will receive escalated dose of HRS-7535 administered orally
Group D	Experimental	Drug: HRS-7535;PlaceboSubjects will receive escalated dose of HRS-7535 administered orally
Group E	Placebo comparator	Drug: PlaceboSubjects will receive Placebo administered orally

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female subjects, 18-65 years of age at the time of signing informed consent;
At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
Able and willing to provide a written informed consent

Key exclusion criteria (13 listed)

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;
History of diabetes;
History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

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
HRS-7535;PlaceboHRS-7535;Placebo	Drug	Group A, Group B, Group C, Group D
PlaceboPlacebo	Drug	Group E

Primary outcome

Percent change in body weight from baseline at Week 26
Time frame: Week 26

11 secondary outcomes

Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36
Time frame: Week 26 and Week 36
Percent change in body weight from baseline at Week 36
Time frame: Week 36
Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in fasting plasma glucoseat Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in fasting serum insulin at Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in HbA1c at Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in total cholesterol (TC) at Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36
Time frame: Week 26 and Week 36
Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3
Time frame: Week 26 and Week 3
Change from baseline in triglycerides (TG) at Week 26 and Week 36
Time frame: Week 26 and Week 36

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 13 Apr 2025.
Derived from this study: PubMed 42331800Gu W, Zhang L, Li L, Wei D, Li Q, Zong Y, Ye Z, Shu C, Zhong T, Mu Y. HRS-7535, an oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity without diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Commun. 2026 Jun 22;17(1):7867. doi: 10.1038/s41467-026-73018-y.
Individual participant dataSharing planned: Undecided

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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 of Overweight and Obesity, run by Shandong Suncadia Medicine 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 4 inclusion and 13 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 13 Apr 2025. 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?

Percent change in body weight from baseline at Week 26 (time frame: Week 26). 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 NCT06250946, which also lists 1 linked publication.

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 13 Apr 2025.