Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-4082 Formulation 1 (F1), MK-4082 Formulation 1, MK-4082 Formulation 2 (F2), MK-4082 Formulation 2, MK-4082 Formulation 4 (F4), MK-4082 Formulation 4
MK-4082 · 3 trials · 1 indication
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
Blood samples will be collected to determine the Cmax of MK-4082.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| Panel A Sequence 1 | EXPERIMENTAL | Participants will be administered daily oral doses of MK-4082 formulation 1 (F1) and MK-4082 formulation 2 (F2) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F2 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days. |
| Panel A Sequence 2 | EXPERIMENTAL | Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F2 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F2 for 7 days. |
| Panel B Sequence 1 | EXPERIMENTAL | Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 formulation 4 (F4) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F4 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days. |
| Panel B Sequence 2 | EXPERIMENTAL | Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F4 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F4 for 7 days. |
| MK-4082 | EXPERIMENTAL | Participants will move sequentially through 2 periods in Part 1. In Period 1, participants will receive a single oral dose of MK-4082 on Day 1. In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days. In Part 2 participants receive a single dose of MK-4082 or placebo. |
| Panel A: Dose Escalation to Dosage 1 | EXPERIMENTAL | Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1. |
| Panel B: Dose Escalation to Dosage 2 | EXPERIMENTAL | Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2. |
| Panel C: Dose Escalation to Dosage 3 | EXPERIMENTAL | Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3. |
| Panel D: Dose Escalation to Dosage 4 | EXPERIMENTAL | Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4. |
| Panel E: Dose Escalation to Dosage 5 | EXPERIMENTAL | Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5. |
| Name | Type | Description |
|---|---|---|
| MK-4082 Formulation 1 (F1) | DRUG | Oral Tablet |
| MK-4082 Formulation 2 (F2) | DRUG | Oral Tablet |
| MK-4082 Formulation 4 (F4) | DRUG | Oral Tablet |
| MK-4082 | DRUG | Oral administration |
| Diltiazem | DRUG | Oral administration |
| Rescue medication | DRUG | All participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting. |
| Placebo | DRUG | Oral Tablet |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is in good health * Has a body mass index (BMI) between 25 and 40 kg/m\^2, inclusive and weighs at least 60 kg Exclusion Criteria: The main exclusion criteria include but are not limited to the follow...
MK-4082 is an investigational small molecule developed by Merck & Company, Inc. (MRK). It is a GLP-1 receptor-targeted agent currently in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. It is being studied in healthy overweight and obese participants.
MK-4082 targets the GLP-1 receptor. GLP-1 is a receptor involved in metabolic signaling, and MK-4082 is a small molecule designed to act at this target. This mechanism places it among GLP-1 receptor-directed therapies, a class being explored for weight and metabolic conditions.
MK-4082 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical program, including Phase 1 trials in healthy participants and in healthy overweight and obese participants in the United States.
MK-4082 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Three Phase 1 trials have been registered, with two currently active and one completed, enrolling a total of 198 participants across the program.
MK-4082 has three registered Phase 1 trials. NCT07388667, in healthy overweight participants, is completed with 122 enrolled. NCT07748351, testing multiple formulations in healthy overweight and obese participants, is active but not recruiting with 48 enrolled. NCT07697625, in healthy participants, is recruiting with 28 enrolled.
Yes. MK-4082 Formulation 1 (F1), MK-4082 Formulation 2 (F2), and MK-4082 Formulation 4 (F4) are alternative names referring to different formulations of the same investigational drug, MK-4082. One Phase 1 trial, NCT07748351, specifically evaluates multiple formulations of MK-4082 in healthy overweight and obese participants.