ObesityPhase 1NCT07269756
A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects
A Phase 1 study testing HRS-7535 Tablets, Paracetamol Tablets and Digoxin Tablets in people with Obesity and Overweight, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, fixed-sequence, self-controlled Phase I clinical trial conducted among obese or overweight subjects, with a planned enrollment of 40 adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- HRS-7535 Tablets, Paracetamol Tablets and Digoxin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2025to 8 Mar 2026
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
- Males or females aged 18-50 years (inclusive);
- Weight ≥ 50.0 kg and <100.0 kg, and body mass index (BMI) ≥26.0 kg/m2;
- Male subjects who are female with fertility or whose partners are female with fertility must have no plans to have children or donate sperm/eggs from the date of signing the informed consent form until one month after the last medication use, and voluntarily take effective contraceptive measures (including for their partners).
Who cannot join
- Those with a history of drug or food allergies, or those with an allergic constitution;
- History of inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors that affect drug administration and absorption;
- History of diabetes (except gestational diabetes);
- Those with a history of severe hypoglycemia;
- There is a history of clinical gastric emptying abnormalities (such as gastric outlet obstruction) and severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcers) in the past;
- Those with a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, acute or chronic pancreatitis, symptomatic gallbladder diseases or cholestasis;
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- Any malignant tumor of the organ system has occurred within 5 years, regardless of whether there is evidence of local recurrence or metastasis. Local basal cell carcinoma of the skin, cervical carcinoma in situ and prostate carcinoma in situ are excluded;
- Those who have undergone any surgery within the six months prior to screening;
- Severe cardiovascular and cerebrovascular diseases have occurred within 6 months prior to screening, including but not limited to: heart failure (NYHA grade II-IV), angina pectoris, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, etc. And/or planned to undergo coronary, carotid or peripheral artery revascularization at the time of screening;
- Those who frequently consumed alcohol within the six months prior to the screening, that is, those who consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 100 mL of wine), and who could not stop using any alcoholic products during the trial period, and whose breath test for alcohol was positive;
- Those who have participated in any clinical trials of drugs or medical devices within the three months prior to screening (based on the intervention of the trial drugs or medical devices);
- Those who smoked more than five cigarettes per day in the three months prior to screening and were unable to stop using any tobacco products during the trial period;
- Those who have donated blood (or lost blood) within 3 months prior to screening with a blood donation (or blood loss) volume of ≥ 400 mL, or have received blood transfusion;
- Those who have experienced any acute disease that has been determined to have clinical significance by the researchers within one month prior to screening;
- Those who have received a vaccine within one month before screening or plan to receive a vaccine during the trial period;
- Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to screening and/or baseline, and plan to take drugs or health supplements other than those tested in this study during the trial period;
- Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal peristalsis for a long time. For example: having undergone bariatric surgery or procedures (such as gastric banding), or having used weight-reducing drugs (including but not limited to orlistat) within 3 months prior to administration, or reporting a weight change of more than 5kg within 3 months prior to administration;
- During screening, a 12-lead electrocardiogram (ECG) examination showed that the QTcF was ≥450 ms in males and ≥470 ms in females, or that the ECG had other abnormal conditions that the researcher judged to be of clinical significance;
- Those with a history of drug abuse, drug dependence (during consultation), or with a positive result in pre-administration urine drug abuse screening;
- Abnormal and clinically significant examination results such as laboratory tests, physical examinations, vital signs, abdominal ultrasound, chest X-rays, etc;
- The Investigators considered the subjects to have other factors that made them unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Fixed-sequence, Self-controlled Pharmacokinetic Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects
This study is an open-label, fixed-sequence, self-controlled Phase I clinical trial conducted among obese or overweight subjects, with a planned enrollment of 40 adult subjects.
- Conditions
- Obesity, Overweight
- Being tested
- HRS-7535 Tablets, Paracetamol Tablets, Digoxin Tablets, Rosuvastatin Calcium Tablets, Omeprazole Enteric-coated Capsules
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535 TabletsDrug
HRS-7535 tablet.
Paracetamol TabletsDrug
Paracetamol tablet.
Digoxin TabletsDrug
Digoxin tablet.
Rosuvastatin Calcium TabletsDrug
Rosuvastatin Calcium tablet.
Omeprazole Enteric-coated CapsulesDrug
Omeprazole Enteric-coated capsule.
| Study group | Role | What they receive |
|---|---|---|
| Oral Medication Group | Experimental | Not described Receives: Drug: HRS-7535 Tablets; Drug: Paracetamol Tablets; Drug: Digoxin Tablets; Drug: Rosuvastatin Calcium Tablets; Drug: Omeprazole Enteric-coated Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: 63 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)
Measured: 63 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Measured: 63 days.
Secondary outcomes (12)
Time of maximum concentration (Tmax)
Pharmacokinetic parameters of HRS-7535.
Measured: 63 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)
Pharmacokinetic parameters of HRS-7535.
Measured: 63 days.
Elimination half-life (t1/2)
Pharmacokinetic parameters of HRS-7535.
Measured: 63 days.
Apparent clearance (CL/F)
Pharmacokinetic parameters of HRS-7535.
Measured: 63 days.
Apparent volume of distribution (Vz/F)
Pharmacokinetic parameters of HRS-7535.
Measured: 63 days.
Apparent volume of distribution (Vz/F)
Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole.
Measured: 63 days.
Apparent clearance (CL/F)
Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole.
Measured: 63 days.
Elimination half-life (t1/2)
Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole.
Measured: 63 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)
Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole.
Measured: 63 days.
Time of maximum concentration (Tmax)
Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole.
Measured: 63 days.
Incidence of adverse events (AEs)
Safety measures.
Measured: 70 days.
Incidence of serious adverse events (SAEs)
Safety measures.
Measured: 70 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start7 Dec 2025
- Primary completion8 Mar 2026
- Study completion8 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT07269756
- Sponsor's protocol ID
- HRS-7535-110
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2025
- Last updated
- 29 Jun 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Fixed-sequence, Self-controlled Pharmacokinetic Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects
- ClinicalTrials.gov ID
- NCT07269756
- Acronym / sponsor ID
- HRS-7535-110
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2025 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 8 Dec 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.
This study is an open-label, fixed-sequence, self-controlled Phase I clinical trial conducted among obese or overweight subjects, with a planned enrollment of 40 adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Medication Group | Experimental | Drug: HRS-7535 Tablets, Drug: Paracetamol Tablets, Drug: Digoxin Tablets, Drug: Rosuvastatin Calcium Tablets, Drug: Omeprazole Enteric-coated Capsules |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
- Males or females aged 18-50 years (inclusive);
- Weight ≥ 50.0 kg and <100.0 kg, and body mass index (BMI) ≥26.0 kg/m2;
- Male subjects who are female with fertility or whose partners are female with fertility must have no plans to have children or donate sperm/eggs from the date of signing the informed consent form until one month after the last medication use, and voluntarily take effective contraceptive measures (including for their partners).
Key exclusion criteria (21 listed)
- Those with a history of drug or food allergies, or those with an allergic constitution;
- History of inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors that affect drug administration and absorption;
- History of diabetes (except gestational diabetes);
- Those with a history of severe hypoglycemia;
- There is a history of clinical gastric emptying abnormalities (such as gastric outlet obstruction) and severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcers) in the past;
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 tablet. | Drug | Oral Medication Group |
| Paracetamol TabletsParacetamol tablet. | Drug | Oral Medication Group |
| Digoxin TabletsDigoxin tablet. | Drug | Oral Medication Group |
| Rosuvastatin Calcium TabletsRosuvastatin Calcium tablet. | Drug | Oral Medication Group |
| Omeprazole Enteric-coated CapsulesOmeprazole Enteric-coated capsule. | Drug | Oral Medication Group |
Primary outcome
Maximum concentration (Cmax)
Time frame: 63 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)
Time frame: 63 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: 63 days.
12 secondary outcomes
Time of maximum concentration (Tmax)
Time frame: 63 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)
Time frame: 63 days.
Elimination half-life (t1/2)
Time frame: 63 days.
Apparent clearance (CL/F)
Time frame: 63 days.
Apparent volume of distribution (Vz/F)
Time frame: 63 days.
Apparent volume of distribution (Vz/F)
Time frame: 63 days.
Apparent clearance (CL/F)
Time frame: 63 days.
Elimination half-life (t1/2)
Time frame: 63 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)
Time frame: 63 days.
Time of maximum concentration (Tmax)
Time frame: 63 days.
Incidence of adverse events (AEs)
Time frame: 70 days.
Incidence of serious adverse events (SAEs)
Time frame: 70 days.
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 29 Jun 2026.
- 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 1 study testing HRS-7535 Tablets, Paracetamol Tablets and Digoxin Tablets in people with Obesity and Overweight, 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 21 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 29 Jun 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. 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 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.
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?
Maximum concentration (Cmax) (time frame: 63 days.). The study lists 3 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 29 Jun 2026.