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COMPLETEDPHASE1

A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants

A Phase 1, Open-Label Study to Evaluate the Mutual Drug-Drug Interaction Potential Between Denifanstat and Resmetirom in Healthy Adult Participants

NCT07216313•Sagimet Biosciences Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, 2-cohort study to evaluate the mutual DDI potential between denifanstat and resmetirom in healthy adult participants.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Seated blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit.
•Seated pulse rate is ≥ 40 bpm and ≤ 99 bpm at the screening visit.
•QTcF interval is ≤ 460 msec (males) and ≤ 470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
•Liver function test including ALT, AST, ALP and total bilirubin ≤ upper limit of normal at the screening visit.
•Estimated CrCL ≥ 80 mL/min at the screening visit.

Exclusion Criteria

•Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
•History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
•Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
•History or presence of hepatobiliary or thyroid-related disease.
•Significant change (approximately 10% increase or decrease) in weight within 3 months prior to first dosing in the opinion of the PI or designee.
•History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
•Positive results for HIV, HBsAg, or HCV at the screening visit.
•Poor peripheral venous access.

Locations (1)

Celerion

Tempe, Arizona, United States

Key Dates

Start Date

September 30, 2025

Primary Completion Date

October 20, 2025

Completion Date

October 20, 2025

Last Updated

January 23, 2026

Enrollment

ACTUAL participants

Conditions

Healthy

Interventions

Denifanstat

DRUG

Resmetirom

DRUG

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RECRUITING

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants

Inclusion Criteria

Exclusion Criteria

A New Portable Device for Non-invasive Ventilatory Support

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

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