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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7079-008 | Other Identifier | Merck protocol number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 497079 | Experimental | SCH 497079, administered orally, once daily |
|
| Placebo | Placebo Comparator | Placebo capsules, administered orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 497079 | Drug | 100 mg capsule administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCH 497079 | SCH 497079, administered orally, once daily |
| FG001 | Placebo | Placebo capsules, administered orally, once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCH 497079 | SCH 497079, administered orally, once daily |
| BG001 | Placebo | Placebo capsules, administered orally, once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Kilogram | Baseline and Week 12 |
|
Serious adverse events: Up to 16 weeks (including 30 days after the last dose of study drug); non-serious adverse events: up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCH 497079 | SCH 497079, administered orally, once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| Drug |
Placebo capsules matching SCH 497079 administered orally |
|
| 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. |
| Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baeline and Week 12 |
| Withdrew - reason unrelated to treatment |
|
| Protocol Violation |
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| Did not meet protocol eligibility |
|
| Administrative |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo capsules, administered orally, once daily |
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | Baseline and Week 12 |
|
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | Baseline and Week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | Centimeters | Baseline and Week 12 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | kg/m^2 | Baeline and Week 12 |
|
|
|
|
| 5 |
| 267 |
| 142 |
| 267 |
| EG001 | Placebo | Placebo capsules, administered orally, once daily | 1 | 134 | 26 | 134 |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
| D013568 | Pathological Conditions, Signs and Symptoms |