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Healthy volunteers help uncover drug interaction risks

NCT ID NCT07216313

Knowledge-focused Sponsor: Sagimet Biosciences Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study involved 40 healthy adults to see how two experimental drugs, denifanstat and resmetirom, affect each other's levels in the body. Participants took both drugs, and researchers measured drug concentrations in the blood. The goal was to understand if one drug changes how the other is processed, which helps guide safe dosing in future studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

40 people

The number who actually took part.

Started

Sep 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Additional inclusion and exclusion criteria may apply. 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Celerion

    Tempe, Arizona, 85283, United States

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