Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4074 · 1 trial · 1 indication
Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
| Arm | Type | Description |
|---|---|---|
| MK-4074 | EXPERIMENTAL | Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks. |
| Placebo for MK-4074 | PLACEBO_COMPARATOR | Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks. |
| Pioglitazone | EXPERIMENTAL | Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks. |
| Placebo for pioglitazone | PLACEBO_COMPARATOR | Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| MK-4074 200 mg | DRUG | 2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks |
| Placebo for MK-4074 | DRUG | 2 x 100-mg capsules, orally, BID for 4 weeks. |
| Pioglitazone hydrochloride 30 mg | DRUG | 1 x 30-mg tablet, orally, once daily for 4 weeks |
| Placebo for pioglitazone hydrochloride | DRUG | 1 x 30-mg tablet, orally, once daily for 4 weeks |
Inclusion Criteria: * Females must be of non-childbearing potential * Body mass index (BMI) ≥32.0 kg/m\^2 * In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests * No clinically significant abnormality on electrocardiogram * Has document...
MK-4074 is an investigational small molecule developed by Merck & Company, Inc. (MRK) for non-alcoholic fatty liver disease. It has been studied in a Phase 1 clinical trial and is also referred to as MK-4074 200 mg. It is not approved for any indication.
MK-4074 is being developed for the treatment of non-alcoholic fatty liver disease. Its only clinical trial evaluated changes in hepatic fat in patients with this condition. The drug remains investigational and has not been approved for any use.
MK-4074 is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. Merck is the sponsor of the clinical program for this investigational small molecule.
MK-4074 is in Phase 1 clinical development. The single completed trial, NCT01431521, was a Phase 1 study. The drug is investigational and has not received FDA approval.
MK-4074 has been studied in one completed Phase 1 trial, NCT01431521, titled "Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)." It enrolled 31 participants with non-alcoholic fatty liver disease and was randomized, double-blind, and placebo-controlled.