Adults 18 to 70, male only, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced at Least One Adverse Event (AE) (Part 1)Primary· From Day 1 through post-trial visit (Up to 8 weeks)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 1 Panel A MK-8521 100μg
3
Part 1 Panel A MK-8521 300μg
4
Part 1 Panel B MK-8521 150μg
2
Part 1 Panel B MK-8521 175μg
0
Part 1 Panel B MK-8521 200μg
5
Part 1, Pooled Placebo
10
Number of Participants Who Discontinued Treatment Due to an AE (Part 1)Primary· Up to 8 weeks (Part 1)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 1 Panel A MK-8521 100μg
0
Part 1 Panel A MK-8521 300μg
0
Part 1 Panel B MK-8521 150μg
0
Part 1 Panel B MK-8521 175μg
0
Part 1 Panel B MK-8521 200μg
0
Part 1, Pooled Placebo
1
Area Under the Concentration Time Curve of MK-8521 From 0 to Infinity (AUC0-∞) After a Single Dose (Part 1)Primary· Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Group
Value
95% CI
Part 1 Panel A MK-8521 100μg
48.7
± 16.4
Part 1 Panel A MK-8521 300μg
163
± 6.37
Part 1 Panel B MK-8521 150μg
84.4
± 20.3
Part 1 Panel B MK-8521 175μg
101
± 6.07
Part 1 Panel B MK-8521 200μg
109
± 25.7
Peak Plasma Concentration (Cmax) of Participants Treated With a Single Dose of MK-8521 (Part 1)Primary· Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Group
Value
95% CI
Part 1 Panel A MK-8521 100μg
1.24
± 30.2
Part 1 Panel A MK-8521 300μg
4.29
± 23.5
Part 1 Panel B MK-8521 150μg
2.63
± 20.0
Part 1 Panel B MK-8521 175μg
3.10
± 20.8
Part 1 Panel B MK-8521 200μg
3.54
± 18.4
Time Taken to Reach Cmax (Tmax) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 1)Primary· Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. No pharmacokinetic analysis was performed on participants receiving Placebo.
Group
Value
95% CI
Part 1 Panel A MK-8521 100μg
14
8 – 30
Part 1 Panel A MK-8521 300μg
10
4 – 16
Part 1 Panel B MK-8521 150μg
11
10 – 16
Part 1 Panel B MK-8521 175μg
12
8 – 12
Part 1 Panel B MK-8521 200μg
14
10 – 16
Apparent Terminal Half-life (t1/2) for Plasma Concentration of Participants Treated With a Single Dose of MK-8521 (Part 1)Primary· Pre-dose, 0.5, 1, 2, 4, 8, 10, 12, 14, 16, 24, 30, 34, 48, 72, 96, 120 hrs. post-dose (Part 1)
Apparent Terminal Half-life (t1/2) is the time required for a given drug concentration in the plasma to decrease by 50%. A summary of pharmacokinetic parameters following administration of single SC (subcutaneous) injection of MK-8521 in healthy non-obese male participants (Part I, Panels A-B, Period 1-3 \[100-300μg\]) is presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo.
Group
Value
95% CI
Part 1 Panel A MK-8521 100μg
13.8
± 15.5
Part 1 Panel A MK-8521 300μg
13.7
± 8.93
Part 1 Panel B MK-8521 150μg
14.8
± 6.45
Part 1 Panel B MK-8521 175μg
14.1
± 2.64
Part 1 Panel B MK-8521 200μg
13.8
± 12.9
Number of Participants With an Adverse Event (AE) (Part 2)Primary· From Day 1 through post-trial visit (Up to 7 weeks)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
5
Part 2 Panel D MK-8521 100/150μg
5
Part 2 Panel E MK-8521 125/150μg
5
Part 2 Panel F MK-8521 72/125μg
4
Part 2, Pooled Placebo
3
Number of Participants Who Discontinued Treatment Due to an AE (Part 2)Primary· Up to 7 weeks (Part 2)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adver
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
0
Part 2 Panel D MK-8521 100/150μg
1
Part 2 Panel E MK-8521 125/150μg
0
Part 2 Panel F MK-8521 72/125μg
0
Part 2, Pooled Placebo
0
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)Primary· Days 1, 5 and 10 (Part 2) (Panels C, D, E)
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part II, Panel C, D, and E) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points fo
Day 1
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
12.0
± 21.3
Part 2 Panel D MK-8521 100/150μg
23.1
± 18.9
Part 2 Panel E MK-8521 125/150μg
33.5
± 16.4
Day 5
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
22.8
± 20.7
Part 2 Panel D MK-8521 100/150μg
43.3
± 23.6
Part 2 Panel E MK-8521 125/150μg
60.7
± 19.8
Day 10
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
35.1
± 19.0
Part 2 Panel D MK-8521 100/150μg
86.8
± 34.4
Part 2 Panel E MK-8521 125/150μg
77.8
± 15.0
AUC 0-24hr for Plasma Concentration of Participants Treated After Multiple Doses of MK-8521 (Part 2, Panel F)Primary· Days 1, 7 and 14 (Part 2) (Panel F)
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel F: Days
Day 1
Group
Value
95% CI
Part 2 Panel F MK-8521 72/125μg
8.85
± 22.1
Day 7
Group
Value
95% CI
Part 2 Panel F MK-8521 72/125μg
24.8
± 21.6
Day 14
Group
Value
95% CI
Part 2 Panel F MK-8521 72/125μg
54.6
± 17.9
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panels C, D, and E)Primary· Days 1, 5 and 10 (Part 2) (Panels C, D, E)
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 10 Days (with dose escalation on Day 5) to healthy non-obese male participants (Part 2, Panel C, D, E and F) are presented. Method of dispersion is coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel
Day 1
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
0.642
± 21.8
Part 2 Panel D MK-8521 100/150μg
1.25
± 20.0
Part 2 Panel E MK-8521 125/150μg
1.85
± 23.1
Day 5
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
1.11
± 22.6
Part 2 Panel D MK-8521 100/150μg
2.21
± 23.1
Part 2 Panel E MK-8521 125/150μg
3.12
± 16.0
Day 10
Group
Value
95% CI
Part 2 Panel C MK-8521 50/72μg
1.73
± 20.4
Part 2 Panel D MK-8521 100/150μg
4.31
± 35.9
Part 2 Panel E MK-8521 125/150μg
3.73
± 13.0
Cmax for Plasma Concentration of Participants Treated With Multiple Doses of MK-8521 (Part 2, Panel F)Primary· Days 1, 7 and 14 (Part 2) (Panel F)
AUC0-24hr is a measure of the mean concentration levels of drug in the plasma 0 to 24 hrs. after the dose. Mean pharmacokinetic parameter values for MK-8521 following administration of multiple subcutaneous once daily doses for 14 Days (with dose escalation on Day 7) to obese male participants (Part 2, Panel F) are presented. Method of dispersion coefficient of variation (%CV). No pharmacokinetic analysis was performed on participants receiving Placebo. Blood collections for the determination of plasma MK-8521 concentrations were collected at the following time points for Part 2, Panel F: Days
Day 1
Group
Value
95% CI
Part 2 Panel F MK-8521 72/125μg
0.511
± 22.7
Day 7
Group
Value
95% CI
Part 2 Panel F MK-8521 72/125μg
1.15
± 22.8
Day 14
Group
Value
95% CI
Part 2 Panel F MK-8521 72/125μg
2.56
± 19.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Day 42.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8521.
Part 1 primary hypothesis: Administration of single subcutaneous (SC) doses of MK-8521 is sufficiently safe and well- tolerated in healthy participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.
Part 2: Administration of multiple once daily SC doses of MK-8521 is sufficiently safe and well-tolerated in healthy lean and obese participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 2 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02055547.