Denifanstat + Resmetirom for Healthy Subjects

Overseen By Study Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sagimet Biosciences Inc.

Disqualifiers: Metabolic, Hepatic, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the interaction between two drugs, denifanstat and resmetirom, in the body. Researchers are examining how one drug affects the absorption and behavior of the other. Participants will be divided into two groups to observe these effects in detail. The trial seeks healthy adults with normal liver and kidney function, without any significant medical history that could affect drug absorption or metabolism. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that denifanstat is generally well-tolerated. It met all primary and secondary goals in an acne trial, with most participants experiencing few or no side effects. Similarly, research has shown that resmetirom is also well-tolerated, with safety comparable to a placebo, causing no more side effects than a sugar pill. Past trial data suggest that both treatments appear safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Denifanstat and Resmetirom because they offer a fresh approach to understanding how these drugs interact with each other in the body. Unlike current treatments, which often focus on single-drug effects, this study explores the combined impact on drug metabolism, potentially leading to more effective dosing strategies. Denifanstat and Resmetirom each work differently from traditional options: Denifanstat targets specific enzymes involved in cholesterol synthesis, while Resmetirom acts on thyroid hormone receptors to improve lipid metabolism. This innovative combination could enhance treatment outcomes by optimizing how each drug works together, offering a promising new direction for managing metabolic conditions.

What evidence suggests that this trial's treatments could be effective?

This trial examines how denifanstat and resmetirom affect each other's pharmacokinetics. Previous studies have shown that denifanstat significantly reduces both inflammatory and non-inflammatory acne, achieving success rates more than double those of a placebo. This suggests it can effectively treat skin conditions. Resmetirom has improved liver health by reducing liver fat and fibrosis and enhancing overall metabolic health. Both treatments have demonstrated positive results in their respective areas, supporting their potential effectiveness. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to understand how two drugs, Denifanstat and Resmetirom, interact with each other. Specific eligibility criteria are not provided but typically include factors like age range, absence of chronic conditions, and no current medications that could interfere with the study.

Inclusion Criteria

Seated pulse rate is ≥ 40 bpm and ≤ 99 bpm at the screening visit

Seated blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg 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

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive denifanstat and resmetirom to evaluate drug-drug interaction potential

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Denifanstat
• Resmetirom

Trial Overview

The trial is testing the interaction between two drugs: Denifanstat and Resmetirom. It's an open-label study where everyone knows what treatment they're getting. Participants will be divided into two groups to see if taking one drug affects the activity or side effects of the other.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 2 Interventions

Effect of denifanstat on pharmacokinetics of resmetirom

Group II: Cohort 1 Experimental Treatment 2 Interventions

Effect of resmetirom on pharmacokinetics of denifanstat

Who Is Running the Clinical Trial?

Sagimet Biosciences Inc.

Lead Sponsor

Trials

10

Recruited

3,900+

Citations

1.

ir.sagimet.com

ir.sagimet.com/news-releases/news-release-details/denifanstat-achieved-all-endpoints-treatment-moderate-severe

Denifanstat Achieved All Endpoints in the Treatment of ...

At Week 12, treatment success rates with denifanstat were more than double those of placebo, with marked reductions in both inflammatory and non ...

2.

sagimetbiosciences.gcs-web.com

sagimetbiosciences.gcs-web.com/news-releases/news-release-details/sagimet-biosciences-reports-second-quarter-2025-financial

Sagimet Biosciences Reports Second Quarter 2025 Financial ...

Denifanstat met all primary and secondary endpoints in Phase 3 clinical trial in moderate to severe acne conducted by license partner ...

3.

ir.sagimet.com

ir.sagimet.com/news-releases/news-release-details/sagimet-biosciences-announces-dosing-first-participants-phase-1

News Release

Results from this Phase 1 PK trial will be used to inform the optimal dose levels of denifanstat and resmetirom to evaluate in a Phase 2 ...

4.

biospace.com

biospace.com/sagimet-biosciences-announces-completion-of-phase-1-hepatic-impairment-study-with-fasn-inhibitor-denifanstat

Sagimet Biosciences Announces Completion of Phase 1 ...

This study was designed to assess the safety and pharmacokinetics of denifanstat in subjects with hepatic impairment, a typical requirement of ...

5.

sec.gov

sec.gov/Archives/edgar/data/1400118/000110465925045791/tm2514358d1_ex99-1.htm

99.1

In a Phase 1 clinical trial in patients with and without hepatic impairment, denifanstat exhibited similar pharmacokinetic characteristics and ...

6.

abmole.com

abmole.com/literature/denifanstat-msds.html?srsltid=AfmBOorLaoqw4tTUMV2UpdroOZBPmhvEXVx-hVJ-HLpJGyJxkfHZ5qdX

Material Safety Data Sheet of Denifanstat

Material Safety Data Sheet of Denifanstat contains identification of substance and details of the supplier of the safety data sheet.

7.

ir.sagimet.com

ir.sagimet.com/news-releases/news-release-details/sagimet-receives-fda-breakthrough-therapy-designation

Sagimet Receives FDA Breakthrough Therapy Designation ...

Safety data showed that denifanstat was generally well tolerated. The Company plans to initiate the Phase 3 clinical program for denifanstat ...

8.

cdn.caymanchem.com

cdn.caymanchem.com/cdn/msds/35703m.pdf

Safety Data Sheet

Denifanstat. Fatty Acid Synthase Inhibitor 2. FASN-IN-2. · Article number: 35703. · CAS Number: 1399177-37-7. · Application of the substance ...

9.

thelancet.com

thelancet.com/journals/langas/article/PIIS2468-1253(24)00246-2/fulltext

Denifanstat for the treatment of metabolic dysfunction ...

This study aimed to examine the safety and efficacy of denifanstat for improving liver histology in individuals with MASH and moderate to ...