Hypertension
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of two investigational drugs (MK-0736 and MK-0916) in lowering blood pressure and body weight in patients with hypertension (high blood pressure). This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
Detailed description
Participants enrolled in the study will be separated into 2 strata based on baseline body mass index (BMI) assessments prior to being randomly assigned to study treatment. Study will include a 24-week treatment period comprised of 2 phases, A and B, each of which will 12 weeks in duration.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Hypertension systolic blood pressure (SBP) \</= 160mm Hg and diastolic blood pressure (DBP): 90-105mm Hg
Exclusion criteria
* Pre-menopausal women * patients currently taking more than two (2) blood pressure lowering medications * Body Mas Index (BMI)\>40 kg/m2 (morbidly obese patients) * History of Alcohol abuse (\<3 Years) * History of diabetes,chronic kidney disease, Active liver disease, recent heart attack or stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded. |
| Number of Participants Who Reported a Clinical Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. |
| Number of Participants Who Reported a Laboratory Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. |
| Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination. |
| Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 24 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded. |
| Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | TG measured at baseline and after 12 weeks of study drug administration |
| Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis. |
| Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | Waist circumference measured in cm at baseline and after 12 weeks of study drug administration |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | Baseline and Week 12 (end of Phase A) | LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration. |
| Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | Baseline and Week 12 (end of Phase A) | HDL-C measured at baseline and after 12 weeks of study drug administration. |
Participant flow
Pre-assignment details
Enrolled participants were divided into 2 strata: higher body mass index (BMI) (27 kg/m\^2≤BMI\<41 kg/m\^2) and lower BMI (20 kg/m\^2≤BMI\<27 kg/m\^2) prior to being randomly assigned study treatment. Data from High BMI groups were to be utilized in the primary and secondary analyses; data from low BMI groups were to be utilized in exploratory analyses.
Participants by arm
| Arm | Count |
|---|---|
| High BMI:MK-0736 2mg→Placebo Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) | 54 |
| High BMI:MK-0736 7mg→Placebo Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B) | 54 |
| High BMI:MK-0916 6mg→MK-0916 6mg Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B | 52 |
| High BMI:Placebo→Placebo Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 51 |
| Low BMI:MK-0916 6mg→MK-0916 6mg Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 19 |
| Low BMI:Placebo→Placebo Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks) | 19 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Phase A | Adverse Event | 2 | 3 | 3 | 0 | 2 | 0 |
| Phase A | Completed but did not enter Phase B | 1 | 2 | 2 | 2 | 1 | 1 |
| Phase A | Met criteria for discontinuation | 1 | 1 | 0 | 0 | 0 | 0 |
| Phase A | Other non-reported reason | 4 | 2 | 1 | 2 | 0 | 1 |
| Phase A | Participant moved | 0 | 0 | 1 | 0 | 0 | 1 |
| Phase A | Protocol Violation | 1 | 0 | 0 | 1 | 0 | 0 |
| Phase A | Site Terminated | 0 | 0 | 0 | 1 | 0 | 0 |
| Phase A | Withdrawal by Subject | 2 | 2 | 1 | 3 | 0 | 1 |
| Phase B | Adverse Event | 0 | 0 | 2 | 0 | 0 | 1 |
| Phase B | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Phase B | Other non-reported reason | 0 | 0 | 1 | 1 | 0 | 0 |
| Phase B | Participant moved | 1 | 0 | 0 | 0 | 0 | 0 |
| Phase B | Protocol Violation | 0 | 2 | 0 | 0 | 0 | 0 |
| Phase B | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | High BMI:MK-0736 2mg→Placebo | High BMI:MK-0736 7mg→Placebo | High BMI:MK-0916 6mg→MK-0916 6mg | High BMI:Placebo→Placebo | Low BMI:MK-0916 6mg→MK-0916 6mg | Low BMI:Placebo→Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 21 to 30 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Customized 31 to 40 years | 3 Participants | 3 Participants | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 12 Participants |
| Age, Customized 41 to 50 years | 10 Participants | 17 Participants | 20 Participants | 14 Participants | 6 Participants | 4 Participants | 71 Participants |
| Age, Customized 51 to 60 years | 26 Participants | 20 Participants | 20 Participants | 17 Participants | 9 Participants | 9 Participants | 101 Participants |
| Age, Customized 61 to 70 years | 14 Participants | 12 Participants | 12 Participants | 13 Participants | 4 Participants | 6 Participants | 61 Participants |
| Age, Customized >70 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 30 Participants | 17 Participants | 20 Participants | 13 Participants | 6 Participants | 10 Participants | 96 Participants |
| Sex: Female, Male Male | 24 Participants | 37 Participants | 32 Participants | 38 Participants | 13 Participants | 9 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 54 | 39 / 54 | 37 / 52 | 37 / 51 | 16 / 19 | 11 / 19 |
| serious Total, serious adverse events | 2 / 54 | 1 / 54 | 2 / 52 | 1 / 51 | 2 / 19 | 1 / 19 |
Outcome results
Primary
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -4.2 mm Hg | Standard Deviation 7.3 |
| MK-0736 7.0 mg High BMI | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -2.4 mm Hg | Standard Deviation 8.1 |
| MK-0916 6.0 mg High BMI | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -3.1 mm Hg | Standard Deviation 7.9 |
| Placebo High BMI | Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -0.2 mm Hg | Standard Deviation 8.7 |
p-value: 0.15795% CI: [-5.3, 0.9]ANCOVA
p-value: 0.0195% CI: [-7.1, -1]ANCOVA
p-value: 0.04295% CI: [-6.4, -0.1]ANCOVA
p-value: 0.51795% CI: [-2.1, 4.1]ANCOVA
p-value: 0.60295% CI: [-3.9, 2.3]ANCOVA
Primary
Number of Participants Who Reported a Clinical Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Time frame: 24 weeks
Population: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0736 2.0 mg High BMI | Number of Participants Who Reported a Clinical Adverse Event | 44 Participants |
| MK-0736 7.0 mg High BMI | Number of Participants Who Reported a Clinical Adverse Event | 39 Participants |
| MK-0916 6.0 mg High BMI | Number of Participants Who Reported a Clinical Adverse Event | 38 Participants |
| Placebo High BMI | Number of Participants Who Reported a Clinical Adverse Event | 36 Participants |
| Low BMI:MK-0916 6mg→MK-0916 6mg | Number of Participants Who Reported a Clinical Adverse Event | 16 Participants |
| Low BMI:Placebo→Placebo | Number of Participants Who Reported a Clinical Adverse Event | 11 Participants |
Primary
Number of Participants Who Reported a Laboratory Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Time frame: 24 weeks
Population: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0736 2.0 mg High BMI | Number of Participants Who Reported a Laboratory Adverse Event | 1 Participants |
| MK-0736 7.0 mg High BMI | Number of Participants Who Reported a Laboratory Adverse Event | 2 Participants |
| MK-0916 6.0 mg High BMI | Number of Participants Who Reported a Laboratory Adverse Event | 0 Participants |
| Placebo High BMI | Number of Participants Who Reported a Laboratory Adverse Event | 2 Participants |
| Low BMI:MK-0916 6mg→MK-0916 6mg | Number of Participants Who Reported a Laboratory Adverse Event | 0 Participants |
| Low BMI:Placebo→Placebo | Number of Participants Who Reported a Laboratory Adverse Event | 0 Participants |
Primary
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Time frame: 24 weeks
Population: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0736 2.0 mg High BMI | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 2 Participants |
| MK-0736 7.0 mg High BMI | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 3 Participants |
| MK-0916 6.0 mg High BMI | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 6 Participants |
| Placebo High BMI | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 0 Participants |
| Low BMI:MK-0916 6mg→MK-0916 6mg | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 2 Participants |
| Low BMI:Placebo→Placebo | Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event | 1 Participants |
Primary
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Time frame: 24 weeks
Population: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-0736 2.0 mg High BMI | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 0 Participants |
| MK-0736 7.0 mg High BMI | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 0 Participants |
| MK-0916 6.0 mg High BMI | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 0 Participants |
| Placebo High BMI | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 0 Participants |
| Low BMI:MK-0916 6mg→MK-0916 6mg | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 0 Participants |
| Low BMI:Placebo→Placebo | Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event | 0 Participants |
Secondary
Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
HDL-C measured at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | -1.3 Percent change | Standard Deviation 5.7 |
| MK-0736 7.0 mg High BMI | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | -1.8 Percent change | Standard Deviation 6.7 |
| MK-0916 6.0 mg High BMI | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | 1.6 Percent change | Standard Deviation 6.7 |
| Placebo High BMI | Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI | 1.5 Percent change | Standard Deviation 5 |
p-value: 0.01595% CI: [-11.3, -1.2]ANCOVA
p-value: 0.12495% CI: [-9.2, 1.1]ANCOVA
p-value: 0.42995% CI: [-3.1, 7.2]ANCOVA
p-value: 0.00195% CI: [-13.3, -3.4]ANCOVA
p-value: 0.01895% CI: [-11.1, -1.1]ANCOVA
Secondary
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | -0.6 kg | Standard Deviation 1.8 |
| MK-0736 7.0 mg High BMI | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | -0.9 kg | Standard Deviation 2 |
| MK-0916 6.0 mg High BMI | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | -1.2 kg | Standard Deviation 1.8 |
| Placebo High BMI | Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI | 0.5 kg | Standard Deviation 1.9 |
p-value: <0.00195% CI: [-2.2, -0.7]ANCOVA
p-value: 0.00395% CI: [-1.9, -0.4]ANCOVA
p-value: <0.00195% CI: [-2.4, -1]ANCOVA
p-value: 0.46295% CI: [-0.5, 1]ANCOVA
p-value: 0.11895% CI: [-0.2, 1.3]ANCOVA
Secondary
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -3.5 mm Hg | Standard Deviation 13.2 |
| MK-0736 7.0 mg High BMI | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -4.2 mm Hg | Standard Deviation 12.9 |
| MK-0916 6.0 mg High BMI | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -3.2 mm Hg | Standard Deviation 11.3 |
| Placebo High BMI | Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 0.7 mm Hg | Standard Deviation 12.2 |
p-value: 0.04695% CI: [-9.7, -0.1]ANCOVA
p-value: 0.10895% CI: [-8.7, 0.9]ANCOVA
p-value: 0.09995% CI: [-9, 0.8]ANCOVA
p-value: 0.75295% CI: [-5.7, 4.1]ANCOVA
p-value: 0.94195% CI: [-4.7, 5]ANCOVA
Secondary
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
Waist circumference measured in cm at baseline and after 12 weeks of study drug administration
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | -1.9 cm | Standard Deviation 4.9 |
| MK-0736 7.0 mg High BMI | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | -0.9 cm | Standard Deviation 2.9 |
| MK-0916 6.0 mg High BMI | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | -0.3 cm | Standard Deviation 4.9 |
| Placebo High BMI | Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI | 1.2 cm | Standard Deviation 6.1 |
p-value: 0.05995% CI: [-3.7, 0.1]ANCOVA
p-value: <0.00195% CI: [-5.5, -1.7]ANCOVA
p-value: 0.13695% CI: [-3.3, 0.5]ANCOVA
p-value: 0.68695% CI: [-2.2, 1.4]ANCOVA
p-value: 0.02295% CI: [-4, -0.3]ANCOVA
Secondary
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -1.0 percentage change | Standard Deviation 23.3 |
| MK-0736 7.0 mg High BMI | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | -5.2 percentage change | Standard Deviation 20.4 |
| MK-0916 6.0 mg High BMI | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 4.5 percentage change | Standard Deviation 23 |
| Placebo High BMI | Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 5.7 percentage change | Standard Deviation 30.8 |
p-value: 0.00595% CI: [-20.8, -3.7]ANCOVA
p-value: 0.06695% CI: [-16.7, 0.5]ANCOVA
p-value: 0.31995% CI: [-13.4, 4.4]ANCOVA
p-value: 0.07795% CI: [-16.4, 0.8]ANCOVA
p-value: 0.41895% CI: [-12.2, 5.1]ANCOVA
Secondary
Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
TG measured at baseline and after 12 weeks of study drug administration
Time frame: Baseline and Week 12 (end of Phase A)
Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-0736 2.0 mg High BMI | Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 11.5 Percent change | Standard Deviation 40.3 |
| MK-0736 7.0 mg High BMI | Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 20.1 Percent change | Standard Deviation 54.9 |
| MK-0916 6.0 mg High BMI | Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 11.6 Percent change | Standard Deviation 41.2 |
| Placebo High BMI | Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI) | 11.1 Percent change | Standard Deviation 40.2 |
p-value: 0.58795% CI: [-12.9, 22.8]ANCOVA
p-value: 0.56295% CI: [-23.5, 12.8]ANCOVA
p-value: 0.80295% CI: [-15.8, 20.4]ANCOVA
p-value: 0.77295% CI: [-15.2, 20.5]ANCOVA
p-value: 0.40995% CI: [-25.9, 10.6]ANCOVA