Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01431521 | Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008) | PHASE1 | COMPLETED | 31 | — | — | Oct 26, 2011 | Oct 1, 2012 | Sep 10, 2018 | - | — |
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...