Body Weight, Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.
Detailed description
Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender. Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet. Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.
Interventions
DRUGSCH 497079
100 mg capsule administered orally
DRUGPlacebo
Placebo capsules matching SCH 497079 administered orally
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 18 years of age, of either sex, and of any race. * Obese or overweight participants.
Exclusion criteria
* Participants who have a history of major eating disorders, gastrointestinal (GI) surgery, active serious cardiovascular, pulmonary, endocrine, neurologic, infectious, GI, hepatic, renal, hematologic, immunologic or psychiatric disease or diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Body Weight at Week 12 | Baseline and Week 12 | Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12 | Baseline and Week 12 | For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value. |
| Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12 | Baseline and Week 12 | For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value. |
| Mean Change From Baseline in Waist Circumference at Week 12 | Baseline and Week 12 | Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value. |
| Mean Change From Baseline in Body Mass Index (BMI) at Week 12 | Baeline and Week 12 | For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value. Per protocol, participants were either obese (BMI ≥30 kg/m\^2 and ≤40 kg/m\^2) or overweight (BMI ≥27 kg/m\^2 and \<30 kg/m\^2) at enrollment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SCH 497079 SCH 497079, administered orally, once daily | 267 |
| Placebo Placebo capsules, administered orally, once daily | 134 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 1 | 0 |
| Overall Study | Adverse Event | 85 | 4 |
| Overall Study | Did not meet protocol eligibility | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 4 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Withdrew - reason unrelated to treatment | 11 | 3 |
Baseline characteristics
| Characteristic | SCH 497079 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.2 Years STANDARD_DEVIATION 9.9 | 52.8 Years STANDARD_DEVIATION 10.4 | 53.0 Years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 186 Participants | 93 Participants | 279 Participants |
| Sex: Female, Male Male | 81 Participants | 41 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 142 / 267 | 26 / 134 |
| serious Total, serious adverse events | 5 / 267 | 1 / 134 |
Outcome results
Primary
Mean Change From Baseline in Body Weight at Week 12
Participant's body weight was measured in kilograms. For participants who discontinued during the study, last observation carried forward (LOCF) approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
Time frame: Baseline and Week 12
Population: Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCH 497079 | Mean Change From Baseline in Body Weight at Week 12 | -0.51 Kilogram | Standard Error 0.19 |
| Placebo | Mean Change From Baseline in Body Weight at Week 12 | -0.92 Kilogram | Standard Error 0.26 |
p-value: 0.18795% CI: [-0.2, 1.03]ANOVA
Secondary
Mean Change From Baseline in Body Mass Index (BMI) at Week 12
For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value. Per protocol, participants were either obese (BMI ≥30 kg/m\^2 and ≤40 kg/m\^2) or overweight (BMI ≥27 kg/m\^2 and \<30 kg/m\^2) at enrollment.
Time frame: Baeline and Week 12
Population: Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCH 497079 | Mean Change From Baseline in Body Mass Index (BMI) at Week 12 | -0.18 kg/m^2 | Standard Error 0.07 |
| Placebo | Mean Change From Baseline in Body Mass Index (BMI) at Week 12 | -0.32 kg/m^2 | Standard Error 0.09 |
p-value: 0.23195% CI: [-0.09, 0.35]ANOVA
Secondary
Mean Change From Baseline in Waist Circumference at Week 12
Participant's waist circumference was measured in centimeters. For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
Time frame: Baseline and Week 12
Population: Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SCH 497079 | Mean Change From Baseline in Waist Circumference at Week 12 | -1.22 Centimeters | Standard Error 0.29 |
| Placebo | Mean Change From Baseline in Waist Circumference at Week 12 | -0.94 Centimeters | Standard Error 0.39 |
p-value: 0.54395% CI: [-1.2, 0.63]ANOVA
Secondary
Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12
For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
Time frame: Baseline and Week 12
Population: Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SCH 497079 | Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12 | 1.6 Percentage of participants |
| Placebo | Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12 | 0.8 Percentage of participants |
p-value: 0.51595% CI: [0.24, 9.93]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12
For participants who discontinued during the study, LOCF approach was applied to the analysis. any dropout before Week 12 was included in the analysis if the participant had a valid baseline and at least one post-baseline value.
Time frame: Baseline and Week 12
Population: Intent-to-treat population consisted of all participants who received randomized treatment assignment and had the baseline body weight measurement and at least one post-baseline body weight measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SCH 497079 | Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12 | 7.1 Percentage of participants |
| Placebo | Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12 | 11.5 Percentage of participants |
p-value: 0.1495% CI: [0.28, 1.2]Cochran-Mantel-Haenszel