Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery

Starting soon · Not applicable

Conditions studied: Obesity & Overweight, Bariatric Surgery, Pharmacokinetics After Oral Intake, Drug Absorption

In brief

This prospective, open-label, non-randomized pharmacokinetic study will evaluate how Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy affect systemic exposure to single oral test doses of rosuvastatin and losartan. Sixty adults scheduled for bariatric surgery will enter one of two parallel groups according to the clinically selected operation (30 RYGB and 30 sleeve gastrectomy). Each participant will receive rosuvastatin 10 mg and losartan 25 mg once within 30 days before surgery and again approximately 12 weeks after surgery. Plasma samples collected before dosing and at 1.5 and 4 hours after dosing will be used with maximum a posteriori Bayesian estimation to estimate individual pharmacokinetic parameters. In the 30-participant RYGB group only, paired stool samples will be used to explore gut microbiota and untargeted fecal metabolomic changes. The primary objective is to compare within-participant changes and between-procedure differences in drug exposure after bariatric surgery.

Key facts

Study ID

NCT07748273

Run by

Hospital das Clínicas de Ribeirão Preto

People needed

60

Starts

2026-08-02

Expected to finish

2027-05-15

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 to 65 years;
• Formal clinical indication for RYGB or sleeve gastrectomy after multidisciplinary assessment;
• Bariatric surgery scheduled and no previous bariatric procedure;
• Able to understand the study and provide written informed consent.

You may not qualify if…

• Moderate or severe hepatic impairment, liver enzymes greater than 3 times the upper limit of normal, or Child-Pugh class B or C.
• Estimated glomerular filtration rate below 30 mL/min/1.73 m².
• Concomitant use of drugs that substantially affect rosuvastatin pharmacokinetics and cannot be temporarily discontinued, including cyclosporine, gemfibrozil, or potent OATP1B1/BCRP or CYP2C9 inhibitors.
• Systemic antibiotic use within 3 months or probiotic, prebiotic, or synbiotic use within 4 weeks before sampling.
• Continuous current rosuvastatin or other statin therapy unless medically discontinued with an adequate washout period under physician supervision.
• Clinically relevant baseline hypotension, significant hyperkalemia, renal impairment, or another condition that makes a losartan test dose unsafe.
• Severe postoperative complication preventing oral dosing, including active gastrointestinal leak, intractable vomiting, or severe anastomotic stenosis.
• Pregnancy. Participants of childbearing potential undergo routine preoperative beta-hCG testing.

Where it is running

• Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo — Ribeirão Preto, São Paulo, Brazil

Full record on ClinicalTrials.gov

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