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Overweight or ObesityPhase 1/2NCT06621316

A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects

A Phase 1/2 study testing HRS-7535 Tablet in people with Overweight or 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.

Official record
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Trial summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of HRS-7535 tablet in obese subjects. 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?
HRS-7535 Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteChina
Study dates
30 Oct 2024to 14 Jul 2025
Phase
Phase 1/2
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.
  • At screening: BMI ≥30 kg/m2.
  • Have been controlled by diet and exercise for 3 months or more before screening, and the change in body weight in the past 3 months is less than 5%.
  • Male and female subjects of childbearing potential through signing the informed consent form to 1 month after the last dose have no family plans and must use highly effective contraception, and female participants of childbearing potential also must have no plans to donate eggs (male participants must have no plans to be sperm donors); Female subjects of childbearing potential must have a serum pregnancy test within 7 days prior to the date of randomization, including the day of randomization.

Who cannot join

  • Clinically significant abnormalities in relevant laboratory tests at screening.
  • The results of the electrocardiogram at screening show clinically significant abnormalities that may affect the safety of the subject, including but not limited to myocardial infarction, severe arrhythmias such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.
  • Heart rate or pulse \> 100 beats per minute or ECG QTcF \>450 ms at screening.
  • The PHQ-9 score ≥ 15 points.
  • Poor blood pressure control at screening.
  • Presence or history of endocrine disease that may significantly affect body weight at screening.
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  • History of diabetes mellitus.
  • Within 6 months prior to screening, the subject has the following diseases of clinical significance: including but not limited to neurological, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, blood, immune system and other diseases, which may interfere with the trial results or pose additional risks to the administration of the study drug as judged by the investigator.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
  • Previous or known history of acute or chronic pancreatitis, history of cholecystitis or history of gallstones, chronic malabsorption syndrome or cholestasis.
  • Severe cardiovascular and cerebrovascular diseases within 6 months prior to screening, including but not limited to: heart failure (NYHA grade II-IV), angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, etc.; and/or planned revascularization of the coronary arteries, carotid arteries, or peripheral arteries at the time of screening.
  • Any malignant tumor of any organ system within 5 years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cancer, such as: local basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the prostate.
  • Those who have had serious infections, severe trauma, major and medium-sized surgeries, or planned to undergo surgery during the trial within 6 months prior to screening.
  • Those with or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia or other more serious mental illness; or mentally incapacitated or with a language impairment that is unable to fully understand the trial protocol or is unwilling to collaborate with study center staff.
  • Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease.
  • Presence of any blood disorder (e.g., hemolytic anemia, sickle cell disease, etc.) that may interfere with HbA1c detection.
  • Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis).
  • Use of medications or treatments that may cause significant weight gain or loss within 2 months prior to screening:
  • glucocorticoids (short-term systemic use\< 7 days or topical, inhaled, intraocular and nasal administration);
  • tricyclic antidepressants, atypical antipsychotics and mood stabilizers (such as imipramine, chlorpromazine, amitriptyline, mirtazapine, clozapine, olanzapine, paroxetine, phenelzine, thioridazine, valproic acid and its derivatives, lithium salts, etc.);
  • Orlistat, GLP-1 receptor agonists, or incretins, or other weight-loss therapies other than diet and exercise (including GLP-1 receptor agonists, multi-targeted agents);
  • Other medications or treatments that may significantly affect blood sugar or body weight (eg, metformin, SGLT-2 inhibitors, etc.).
  • Undergoing or planning bariatric surgery or weight-loss therapy based on endoscopy and/or medical devices, etc. during the study period (except for a history of liposuction surgery greater than 1 year).
  • Prior discontinuation of GLP-1 receptor agonist-containing agents for safety and/or tolerability reasons.
  • whichever is longer: Participated in a clinical trial of any drug or medical device within 3 months prior to screening or is still within 5 half-lives of the investigational drug. Participation in clinical trials is defined as: signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Participated in clinical trials of drugs containing GLP-1 receptor agonists (including placebo) within 6 months prior to screening.
  • Known or suspected hypersensitivity to GLP-1 receptor agonist drugs, the investigational drug or its components, or its excipients.
  • Addiction to tobacco and alcohol.
  • Those who have a history of blood donation or blood loss of ≥400ml within 3 months before screening or have received blood transfusion within 2 months.
  • Subjects who are mentally incapacitated or have language impairment who cannot fully understand or participate in the trial process.
  • Females who are pregnant, lactating, planning to become pregnant during the trial, or subjects of childbearing potential who are unwilling to use highly effective contraception during the trial period (starting from signing the informed consent form) and within 1 month after the last dose.
  • Inability to tolerate venipuncture blood sampling or needle phobia.
  • Any condition judged by the investigator to be unsuitable to participate in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 010000

Other trials in China

About this study

Official title: To Explore the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Multiple Doses of HRS-7535 in Obese Subjects

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of HRS-7535 tablet in obese subjects.

Being tested
HRS-7535 Tablet, 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 TabletDrug

    at multiple dose levels

  • PlaceboDrug

    at multiple dose levels (matching active arm HRS-7535 Tablet)

Study groups in NCT06621316
Study groupRoleWhat they receive
Treatment group AExperimentalHRS-7535 Tablet at dose level 1
Receives: Drug: HRS-7535 Tablet
Treatment group BExperimentalHRS-7535 Tablet at dose level 2
Receives: Drug: HRS-7535 Tablet
Treatment group CExperimentalHRS-7535 Tablet at dose level 3
Receives: Drug: HRS-7535 Tablet
Treatment group DExperimentalHRS-7535 Tablet at dose level 4
Receives: Drug: HRS-7535 Tablet
Treatment group EPlacebo comparatorPlacebo at dose level 1
Receives: Drug: Placebo
Treatment group FPlacebo comparatorPlacebo at dose level 2
Receives: Drug: Placebo
Treatment group GPlacebo comparatorPlacebo at dose level 3
Receives: Drug: Placebo
Treatment group HPlacebo comparatorPlacebo at dose level 4
Receives: Drug: Placebo
Treatment group IExperimentalHRS-7535 Tablet at dose level 1 or level 2 or level 3 or level 4.
Receives: Drug: HRS-7535 Tablet
Treatment group JExperimentalHRS-7535 Tablet at dose level 1 or level 2 or level 3 or level 4.
Receives: Drug: HRS-7535 Tablet
Treatment group KPlacebo comparatorPlacebo at dose level 1 or level 2.
Receives: Drug: Placebo
Treatment group LPlacebo comparatorPlacebo at dose level 1 or level 2.
Receives: Drug: Placebo

What is being measured

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

  1. Number of Adverse Events

    Measured: 24 weeks

Secondary outcomes (3)

  1. Pharmacokinetic endpoint: Concentration of HRS-7535 in plasma

    Measured: 24 weeks

  2. Change in fasting weight at week 24

    Measured: 24 weeks

  3. Change in waist circumference at week 24

    Measured: 24 weeks

Timeline

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

  1. First posted1 Oct 2024
  2. Study start30 Oct 2024
  3. Primary completion14 Jul 2025
  4. Study completion14 Jul 2025

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multicenter, randomized, double-blind, placebo parallel-controlled Ib/II clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621316
Sponsor's protocol ID
HRS-7535-107
Status last verified
Aug 2026
First submitted
29 Sep 2024
Last updated
24 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HRS-7535 Tablet in people with Overweight or 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 32 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 24 Aug 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of Adverse Events (time frame: 24 weeks). 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 NCT06621316.

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 24 Aug 2026.

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