Trial Outcomes & Findings for A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004) (NCT NCT02492763)
NCT ID: NCT02492763
Last Updated: 2018-09-10
Results Overview
A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-09-10
Participant Flow
This study was conducted at 84 clinical trial sites in Australia, Colombia, Guatemala, Israel, Spain, New Zealand, and in the United States. Five hundred participants were screened and 176 randomized.
Participant milestones
| Measure |
MK-8521 180 μg
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
44
|
43
|
43
|
|
Overall Study
Treated
|
46
|
44
|
43
|
42
|
|
Overall Study
COMPLETED
|
30
|
29
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
10
|
13
|
Reasons for withdrawal
| Measure |
MK-8521 180 μg
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
2
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Hyperglycemia Discontinuation Criteria
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Non-Compliance With Study Drug
|
0
|
1
|
0
|
0
|
|
Overall Study
Screen Failure
|
0
|
0
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
13
|
10
|
6
|
10
|
Baseline Characteristics
All randomized participants who had a baseline heart rate value.
Baseline characteristics by cohort
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=43 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 Years
STANDARD_DEVIATION 7.6 • n=46 Participants
|
54.2 Years
STANDARD_DEVIATION 7.9 • n=44 Participants
|
51.5 Years
STANDARD_DEVIATION 10.1 • n=43 Participants
|
52.9 Years
STANDARD_DEVIATION 9.4 • n=43 Participants
|
53.2 Years
STANDARD_DEVIATION 8.8 • n=176 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=46 Participants
|
18 Participants
n=44 Participants
|
24 Participants
n=43 Participants
|
20 Participants
n=43 Participants
|
88 Participants
n=176 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=46 Participants
|
26 Participants
n=44 Participants
|
19 Participants
n=43 Participants
|
23 Participants
n=43 Participants
|
88 Participants
n=176 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=46 Participants
|
3 Participants
n=44 Participants
|
2 Participants
n=43 Participants
|
4 Participants
n=43 Participants
|
13 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=46 Participants
|
3 Participants
n=44 Participants
|
4 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
9 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=46 Participants
|
9 Participants
n=44 Participants
|
12 Participants
n=43 Participants
|
7 Participants
n=43 Participants
|
36 Participants
n=176 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=46 Participants
|
25 Participants
n=44 Participants
|
23 Participants
n=43 Participants
|
31 Participants
n=43 Participants
|
106 Participants
n=176 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=46 Participants
|
4 Participants
n=44 Participants
|
2 Participants
n=43 Participants
|
1 Participants
n=43 Participants
|
12 Participants
n=176 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=176 Participants
|
|
Hemoglobin A1C Classification by Levels
<8.5%
|
22 Participants
n=46 Participants
|
24 Participants
n=44 Participants
|
24 Participants
n=43 Participants
|
21 Participants
n=43 Participants
|
91 Participants
n=176 Participants
|
|
Hemoglobin A1C Classification by Levels
>=8.5%
|
24 Participants
n=46 Participants
|
20 Participants
n=44 Participants
|
19 Participants
n=43 Participants
|
22 Participants
n=43 Participants
|
85 Participants
n=176 Participants
|
|
Antihyperglycemic agent (AHA) Washout Status
Yes
|
5 Participants
n=46 Participants
|
5 Participants
n=44 Participants
|
5 Participants
n=43 Participants
|
5 Participants
n=43 Participants
|
20 Participants
n=176 Participants
|
|
Antihyperglycemic agent (AHA) Washout Status
No
|
41 Participants
n=46 Participants
|
39 Participants
n=44 Participants
|
38 Participants
n=43 Participants
|
38 Participants
n=43 Participants
|
156 Participants
n=176 Participants
|
|
Body Mass Index (BMI)
<30 kg/m^2
|
18 Participants
n=46 Participants
|
14 Participants
n=44 Participants
|
15 Participants
n=43 Participants
|
15 Participants
n=43 Participants
|
62 Participants
n=176 Participants
|
|
Body Mass Index (BMI)
>=30 kg/m^2
|
28 Participants
n=46 Participants
|
30 Participants
n=44 Participants
|
28 Participants
n=43 Participants
|
28 Participants
n=43 Participants
|
114 Participants
n=176 Participants
|
|
Heart Rate
|
72.5 Beats/minute
STANDARD_DEVIATION 7.7 • n=46 Participants • All randomized participants who had a baseline heart rate value.
|
72.2 Beats/minute
STANDARD_DEVIATION 9.9 • n=44 Participants • All randomized participants who had a baseline heart rate value.
|
73.8 Beats/minute
STANDARD_DEVIATION 8.6 • n=43 Participants • All randomized participants who had a baseline heart rate value.
|
74.7 Beats/minute
STANDARD_DEVIATION 8.9 • n=42 Participants • All randomized participants who had a baseline heart rate value.
|
73.3 Beats/minute
STANDARD_DEVIATION 8.8 • n=175 Participants • All randomized participants who had a baseline heart rate value.
|
|
Fasting Plasma Glucose (FPG)
|
171.4 mg/dL
STANDARD_DEVIATION 41.0 • n=46 Participants
|
175.0 mg/dL
STANDARD_DEVIATION 49.5 • n=44 Participants
|
172.0 mg/dL
STANDARD_DEVIATION 39.2 • n=43 Participants
|
187.5 mg/dL
STANDARD_DEVIATION 44.9 • n=43 Participants
|
176.4 mg/dL
STANDARD_DEVIATION 43.9 • n=176 Participants
|
|
Fasting Low Density Lipoprotein (LDL) Cholesterol
|
103.3 mg/dL
STANDARD_DEVIATION 28.1 • n=42 Participants • All randomized participants who had a baseline fasting LDL cholesterol value.
|
95.6 mg/dL
STANDARD_DEVIATION 33.8 • n=41 Participants • All randomized participants who had a baseline fasting LDL cholesterol value.
|
100.5 mg/dL
STANDARD_DEVIATION 42.8 • n=40 Participants • All randomized participants who had a baseline fasting LDL cholesterol value.
|
93.0 mg/dL
STANDARD_DEVIATION 29.5 • n=40 Participants • All randomized participants who had a baseline fasting LDL cholesterol value.
|
98.2 mg/dL
STANDARD_DEVIATION 33.9 • n=163 Participants • All randomized participants who had a baseline fasting LDL cholesterol value.
|
|
Fasting High Density Lipoprotein (HDL) Cholesterol
|
47.4 mg/dL
STANDARD_DEVIATION 12.3 • n=42 Participants • All randomized participants who had a baseline fasting HDL cholesterol value.
|
41.7 mg/dL
STANDARD_DEVIATION 9.5 • n=41 Participants • All randomized participants who had a baseline fasting HDL cholesterol value.
|
43.1 mg/dL
STANDARD_DEVIATION 12.0 • n=40 Participants • All randomized participants who had a baseline fasting HDL cholesterol value.
|
46.8 mg/dL
STANDARD_DEVIATION 13.8 • n=40 Participants • All randomized participants who had a baseline fasting HDL cholesterol value.
|
44.8 mg/dL
STANDARD_DEVIATION 12.1 • n=163 Participants • All randomized participants who had a baseline fasting HDL cholesterol value.
|
|
Fasting Triglycerides
|
171.5 mg/dL
STANDARD_DEVIATION 104.6 • n=46 Participants • All randomized participants who had a baseline fasting triglycerides value.
|
167.1 mg/dL
STANDARD_DEVIATION 79.5 • n=44 Participants • All randomized participants who had a baseline fasting triglycerides value.
|
168.7 mg/dL
STANDARD_DEVIATION 96.1 • n=43 Participants • All randomized participants who had a baseline fasting triglycerides value.
|
154.0 mg/dL
STANDARD_DEVIATION 89.5 • n=42 Participants • All randomized participants who had a baseline fasting triglycerides value.
|
165.5 mg/dL
STANDARD_DEVIATION 92.5 • n=175 Participants • All randomized participants who had a baseline fasting triglycerides value.
|
|
Systolic Blood Pressure (SBP)
|
125.1 mm Hg
STANDARD_DEVIATION 10.8 • n=46 Participants
|
126.0 mm Hg
STANDARD_DEVIATION 12.0 • n=44 Participants
|
124.6 mm Hg
STANDARD_DEVIATION 14.3 • n=43 Participants
|
126.3 mm Hg
STANDARD_DEVIATION 11.0 • n=43 Participants
|
125.5 mm Hg
STANDARD_DEVIATION 12.0 • n=176 Participants
|
|
Diastolic Blood Pressure (DBP)
|
76.6 mm Hg
STANDARD_DEVIATION 6.3 • n=46 Participants
|
77.9 mm Hg
STANDARD_DEVIATION 7.4 • n=44 Participants
|
77.6 mm Hg
STANDARD_DEVIATION 8.3 • n=43 Participants
|
78.9 mm Hg
STANDARD_DEVIATION 5.7 • n=43 Participants
|
77.7 mm Hg
STANDARD_DEVIATION 7.0 • n=176 Participants
|
|
Hemoglobin A1C
|
8.54 Percent
STANDARD_DEVIATION 0.82 • n=46 Participants
|
8.43 Percent
STANDARD_DEVIATION 0.78 • n=44 Participants
|
8.46 Percent
STANDARD_DEVIATION 0.83 • n=43 Participants
|
8.72 Percent
STANDARD_DEVIATION 1.03 • n=43 Participants
|
8.54 Percent
STANDARD_DEVIATION 0.87 • n=176 Participants
|
|
Body Weight
|
85.4 Kilograms
STANDARD_DEVIATION 18.1 • n=46 Participants
|
89.4 Kilograms
STANDARD_DEVIATION 20.0 • n=44 Participants
|
90.2 Kilograms
STANDARD_DEVIATION 19.0 • n=43 Participants
|
92.4 Kilograms
STANDARD_DEVIATION 16.5 • n=43 Participants
|
89.3 Kilograms
STANDARD_DEVIATION 18.5 • n=176 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one A1C measurement (baseline or post-baseline).
A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
|
-0.82 Percent
Interval -1.16 to -0.49
|
-1.05 Percent
Interval -1.41 to -0.69
|
-0.44 Percent
Interval -0.8 to -0.08
|
-1.42 Percent
Interval -1.77 to -1.07
|
PRIMARY outcome
Timeframe: Up to Week 14Population: All randomized participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
24 Participants
|
29 Participants
|
25 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: All randomized participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Week 14Population: All randomized participants who received at least 1 dose of study treatment.
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. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With an AE of Symptomatic Hypoglycemia
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one heart rate measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate at Week 12
|
5.47 Beats/minute
Interval 2.99 to 7.96
|
6.28 Beats/minute
Interval 3.72 to 8.84
|
-1.42 Beats/minute
Interval -3.92 to 1.07
|
1.63 Beats/minute
Interval -0.88 to 4.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one body weight measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 body weight minus the Week 0 body weight.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 12
|
-2.0 Kilograms
Interval -2.9 to -1.1
|
-3.0 Kilograms
Interval -4.0 to -2.1
|
-1.3 Kilograms
Interval -2.2 to -0.3
|
-2.9 Kilograms
Interval -3.8 to -1.9
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one FPG measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 FPG minus the Week 0 FPG.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
|
-13.7 mg/dL
Interval -27.7 to 0.3
|
-34.6 mg/dL
Interval -49.3 to -19.9
|
-5.1 mg/dL
Interval -19.4 to 9.2
|
-42.9 mg/dL
Interval -57.0 to -28.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one fasting LDL cholesterol measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol.
Outcome measures
| Measure |
MK-8521 180 μg
n=27 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=26 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=28 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=29 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12
|
-9.3 mg/dL
Standard Deviation 23.5
|
8.8 mg/dL
Standard Deviation 41.8
|
4.5 mg/dL
Standard Deviation 33.5
|
0.3 mg/dL
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one fasting HDL cholesterol measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol.
Outcome measures
| Measure |
MK-8521 180 μg
n=27 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=26 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=28 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=29 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12
|
-0.4 mg/dL
Standard Deviation 12.3
|
-0.5 mg/dL
Standard Deviation 6.0
|
3.8 mg/dL
Standard Deviation 6.6
|
0.4 mg/dL
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one fasting triglycerides measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides.
Outcome measures
| Measure |
MK-8521 180 μg
n=31 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=27 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=31 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=30 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Triglycerides at Week 12
|
-2.9 mg/dL
Standard Deviation 91.9
|
-26.6 mg/dL
Standard Deviation 71.2
|
-15.6 mg/dL
Standard Deviation 68.9
|
-20.5 mg/dL
Standard Deviation 48.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one SBP measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 SBP minus the Week 0 SBP.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
|
-2.7 mmHg
Interval -6.4 to 0.9
|
-1.5 mmHg
Interval -5.2 to 2.3
|
1.0 mmHg
Interval -2.6 to 4.6
|
-1.7 mmHg
Interval -5.3 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: All randomized, treated participants with at least one DBP measurement (baseline or post-baseline).
This change from baseline reflects the Week 12 DBP minus the Week 0 DBP.
Outcome measures
| Measure |
MK-8521 180 μg
n=46 Participants
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 Participants
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 Participants
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 Participants
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
|
0.5 mmHg
Interval -1.7 to 2.8
|
0.4 mmHg
Interval -1.9 to 2.8
|
-1.0 mmHg
Interval -3.3 to 1.3
|
0.6 mmHg
Interval -1.7 to 2.9
|
Adverse Events
MK-8521 180 μg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
MK-8521 300 μg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 1 deaths
Liraglutide 1.8 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-8521 180 μg
n=46 participants at risk
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 participants at risk
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 participants at risk
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 participants at risk
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/46 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/44 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/43 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/42 • Up to Week 14
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. The analysis population included all treated participants.
|
|
General disorders
Death
|
0.00%
0/46 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/44 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/42 • Up to Week 14
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. The analysis population included all treated participants.
|
Other adverse events
| Measure |
MK-8521 180 μg
n=46 participants at risk
Participants receive double-blind MK-8521 180 μg daily (QD), subcutaneously, over 12 weeks.
|
MK-8521 300 μg
n=44 participants at risk
Participants receive double-blind MK-8521 300 μg, QD, subcutaneously, over 12 weeks.
|
Placebo
n=43 participants at risk
Participants receive matching double-blind placebo QD over 12 weeks.
|
Liraglutide 1.8 mg
n=42 participants at risk
Participants receive open-label liraglutide, 1.8 mg QD, subcutaneously, over 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46 • Up to Week 14
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. The analysis population included all treated participants.
|
6.8%
3/44 • Number of events 3 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
2.4%
1/42 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
4/46 • Number of events 5 • Up to Week 14
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. The analysis population included all treated participants.
|
6.8%
3/44 • Number of events 3 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 2 • Up to Week 14
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. The analysis population included all treated participants.
|
7.1%
3/42 • Number of events 4 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
6/46 • Number of events 8 • Up to Week 14
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. The analysis population included all treated participants.
|
15.9%
7/44 • Number of events 10 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
21.4%
9/42 • Number of events 12 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46 • Number of events 2 • Up to Week 14
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. The analysis population included all treated participants.
|
6.8%
3/44 • Number of events 3 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/43 • Up to Week 14
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. The analysis population included all treated participants.
|
2.4%
1/42 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
6/46 • Number of events 7 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/44 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
9.3%
4/43 • Number of events 4 • Up to Week 14
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. The analysis population included all treated participants.
|
2.4%
1/42 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
6.8%
3/44 • Number of events 3 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/43 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/42 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.2%
1/46 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
6.8%
3/44 • Number of events 5 • Up to Week 14
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. The analysis population included all treated participants.
|
7.0%
3/43 • Number of events 3 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/42 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.7%
4/46 • Number of events 4 • Up to Week 14
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. The analysis population included all treated participants.
|
11.4%
5/44 • Number of events 5 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/42 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.2%
1/46 • Number of events 2 • Up to Week 14
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. The analysis population included all treated participants.
|
6.8%
3/44 • Number of events 5 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 2 • Up to Week 14
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. The analysis population included all treated participants.
|
2.4%
1/42 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46 • Up to Week 14
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. The analysis population included all treated participants.
|
9.1%
4/44 • Number of events 5 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/43 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
0.00%
0/42 • Up to Week 14
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. The analysis population included all treated participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/46 • Up to Week 14
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. The analysis population included all treated participants.
|
2.3%
1/44 • Number of events 1 • Up to Week 14
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. The analysis population included all treated participants.
|
9.3%
4/43 • Number of events 5 • Up to Week 14
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. The analysis population included all treated participants.
|
7.1%
3/42 • Number of events 3 • Up to Week 14
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. The analysis population included all treated participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER