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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4082-002 | Other Identifier | MSD |
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Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) of the study medicine that can be used in future studies.
The goals of this study are to learn about:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4082 | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 98 Days |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 84 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082 | Blood samples will be collected to determine the AUC0-24hr of MK-4082. | At designated timepoints (up to 24 hours postdose) |
| Time to Maximum Plasma Concentration (Tmax) of MK-4082 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials ( Site 0005) | Anaheim | California | 92801 | United States | ||
| ProSciento Inc. ( Site 0002) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Placebo | Drug | Oral Tablet |
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Blood samples will be collected to determine the Tmax of MK-4082.
| Predose and at designated timepoints up to 84 Days postdose |
| Maximum Plasma Concentration (Cmax) of MK-4082 | Blood samples will be collected to determine the Cmax of MK-4082. | Predose and at designated timepoints up to 84 Days postdose |
| Plasma Concentration at 24 Hours (C24) of MK-4082 | Blood samples will be collected to determine the C24 of MK-4082. | At designated timepoints up to 24 hours postdose |
| Area Under the Curve from Time 0 to Infinity (AUC0-Inf) of MK-4082 | Blood samples will be collected to determine the AUC0-Inf of MK-4082. | Predose and at designated timepoints up to 84 Days postdose |
| Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082 | Blood samples will be collected to determine the AUC0-last of MK-4082. | Predose and at designated timepoints up to 84 Days postdose |
| Apparent Clearance (CL/F) of MK-4082 | Blood samples will be collected to determine the CL/F of MK-4082. | Predose and at designated timepoints up to 84 Days postdose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082 | Blood samples will be collected to determine the Vz/F of MK-4082. | Predose and at designated timepoints up to 84 Days postdose |
| Apparent Terminal Half-life (t1/2) of MK-4082 | Blood samples will be collected to determine the t1/2of MK-4082. | Predose and at designated timepoints up to 84 Days postdose |
| Change from Baseline in Body Weight | Change from baseline in body weight will be reported. | Baseline and up to approximately 84 Days |
| Change from Baseline in Body Mass Index (BMI) | Change from baseline in body mass index (BMI) will be reported. | Baseline and up to approximately 84 Days |
| Chula Vista |
| California |
| 91911 |
| United States |
| QPS-MRA, LLC ( Site 0003) | South Miami | Florida | 33143 | United States |
| Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0004) | Springfield | Missouri | 65802 | United States |
| Hassman Research Institute Marlton Site ( Site 0006) | Marlton | New Jersey | 08053 | United States |