Denifanstat + Resmetirom for Healthy Subjects
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.12345
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.56789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive denifanstat and resmetirom to evaluate drug-drug interaction potential
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Denifanstat
- Resmetirom
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sagimet Biosciences Inc.
Lead Sponsor