A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects

NCT07269756 | Completed Phase 1

• 1 other identifier: HRS-7535-110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax)

  63 days.

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)

  63 days.

• Area under the concentration-time curve from time zero to infinity (AUC0-inf)

  63 days.

Secondary Outcomes (12)

• Time of maximum concentration (Tmax)

  63 days.

• Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)

  63 days.

• Elimination half-life (t1/2)

  63 days.

• Apparent clearance (CL/F)

  63 days.

• Apparent volume of distribution (Vz/F)

  63 days.

Study Arms (1)

Oral Medication Group

EXPERIMENTAL

Drug: HRS-7535 Tablets; Drug: Paracetamol Tablets; Drug: Digoxin Tablets; Drug: Rosuvastatin Calcium Tablets; Drug: Omeprazole Enteric-coated Capsules

Interventions

HRS-7535 Tablets DRUG

HRS-7535 tablet.

Oral Medication Group

Paracetamol Tablets DRUG

Paracetamol tablet.

Oral Medication Group

Digoxin Tablets DRUG

Digoxin tablet.

Oral Medication Group

Rosuvastatin Calcium Tablets DRUG

Rosuvastatin Calcium tablet.

Oral Medication Group

Omeprazole Enteric-coated Capsules DRUG

Omeprazole Enteric-coated capsule.

Oral Medication Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Acetaminophen; Digoxin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Sulfonamides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: December 8, 2025
• Primary Completion: March 8, 2026
• Study Completion: March 8, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)