CompletedPhase 1

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

China40 participantsStarted 2025-12-08

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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;

What they're measuring

Maximum concentration (Cmax)

Timeframe: 63 days.

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

Timeframe: 63 days.

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

Timeframe: 63 days.

Trial details

NCT IDNCT07269756

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-08

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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;