OverweightPhase 3NCT06904105
A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity
A Phase 3 study testing HRS-7535 Tablets in people with Overweight and Obesity, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- HRS-7535 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 12 Jun 2026
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On the day of signing the informed consent form, the age should be between 18 and 75 years old.
- At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
- The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
- Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.
Who cannot join
- At the screening period, relevant laboratory test results are abnormal.
- Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
- Uncontrolled severe hypertension at the screening period.
- Presence of endocrine diseases that may significantly affect the body weight.
- History of acute or chronic pancreatitis.
- History of significant gastrointestinal diseases.
Show all 10Show fewer
- Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
- Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
- Known or suspected abuse of alcohol or narcotics.
- Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity
The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.
- Conditions
- Overweight, Obesity
- Being tested
- HRS-7535 Tablets, HRS-7535 Placebo Tablets
- 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 TabletsDrug
HRS-7535 tablets.
HRS-7535 Placebo TabletsDrug
HRS-7535 placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| HRS-7535 Group | Experimental | Not described Receives: Drug: HRS-7535 Tablets |
| HRS-7535 Placebo Group | Placebo comparator | Not described Receives: Drug: HRS-7535 Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight relative to the baseline
Measured: 44th week after administration.
Proportion of participants with a body weight reduction of ≥ 5% relative to the baseline
Measured: 44th week after administration.
Secondary outcomes (5)
Proportion of participants with a body weight reduction of ≥10% and ≥15% relative to baseline
Measured: 44th week and 50th week after administration
Change in waist circumference relative to baseline
Measured: 44th week and 50th week after administration
Percentage change in body weight relative to baseline
Measured: 50th week after administration
Proportion of participants with a body weight reduction of ≥5%
Measured: 50th week after administration
Adverse events
Measured: The entire process of the trial, about 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start10 Apr 2025
- Primary completion17 Apr 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904105
- Sponsor's protocol ID
- HRS-7535-303
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06904105
- Acronym / sponsor ID
- HRS-7535-303
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 1 Apr 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.
The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-7535 Group | Experimental | Drug: HRS-7535 Tablets |
| HRS-7535 Placebo Group | Placebo comparator | Drug: HRS-7535 Placebo Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- On the day of signing the informed consent form, the age should be between 18 and 75 years old.
- At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
- The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
- Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.
Key exclusion criteria (10 listed)
- At the screening period, relevant laboratory test results are abnormal.
- Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
- Uncontrolled severe hypertension at the screening period.
- Presence of endocrine diseases that may significantly affect the body weight.
- History of acute or chronic pancreatitis.
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 TabletsHRS-7535 tablets. | Drug | HRS-7535 Group |
| HRS-7535 Placebo TabletsHRS-7535 placebo tablets. | Drug | HRS-7535 Placebo Group |
Primary outcome
Percentage change in body weight relative to the baseline
Time frame: 44th week after administration.
Proportion of participants with a body weight reduction of ≥ 5% relative to the baseline
Time frame: 44th week after administration.
5 secondary outcomes
Proportion of participants with a body weight reduction of ≥10% and ≥15% relative to baseline
Time frame: 44th week and 50th week after administration
Change in waist circumference relative to baseline
Time frame: 44th week and 50th week after administration
Percentage change in body weight relative to baseline
Time frame: 50th week after administration
Proportion of participants with a body weight reduction of ≥5%
Time frame: 50th week after administration
Adverse events
Time frame: The entire process of the trial, about 52 weeks.
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 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 3 study testing HRS-7535 Tablets in people with 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 10 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 27 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in body weight relative to the baseline (time frame: 44th week after administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.