Trial Outcomes & Findings for Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED) (NCT NCT00642993)
NCT ID: NCT00642993
Last Updated: 2018-09-10
Results Overview
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.
COMPLETED
PHASE2
401 participants
Baseline and Week 12
2018-09-10
Participant Flow
Participant milestones
| Measure |
SCH 497079
SCH 497079, administered orally, once daily
|
Placebo
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Overall Study
STARTED
|
267
|
134
|
|
Overall Study
COMPLETED
|
161
|
118
|
|
Overall Study
NOT COMPLETED
|
106
|
16
|
Reasons for withdrawal
| Measure |
SCH 497079
SCH 497079, administered orally, once daily
|
Placebo
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
85
|
4
|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Withdrew - reason unrelated to treatment
|
11
|
3
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Did not meet protocol eligibility
|
0
|
1
|
|
Overall Study
Administrative
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)
Baseline characteristics by cohort
| Measure |
SCH 497079
n=267 Participants
SCH 497079, administered orally, once daily
|
Placebo
n=134 Participants
Placebo capsules, administered orally, once daily
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 Years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
52.8 Years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
53.0 Years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
279 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
SCH 497079
n=255 Participants
SCH 497079, administered orally, once daily
|
Placebo
n=130 Participants
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Mean Change From Baseline in Body Weight at Week 12
|
-0.51 Kilogram
Standard Error 0.19
|
-0.92 Kilogram
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
SCH 497079
n=255 Participants
SCH 497079, administered orally, once daily
|
Placebo
n=130 Participants
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12
|
7.1 Percentage of participants
|
11.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
SCH 497079
n=255 Participants
SCH 497079, administered orally, once daily
|
Placebo
n=130 Participants
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12
|
1.6 Percentage of participants
|
0.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
SCH 497079
n=242 Participants
SCH 497079, administered orally, once daily
|
Placebo
n=126 Participants
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Mean Change From Baseline in Waist Circumference at Week 12
|
-1.22 Centimeters
Standard Error 0.29
|
-0.94 Centimeters
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baeline and Week 12Population: 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.
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.
Outcome measures
| Measure |
SCH 497079
n=255 Participants
SCH 497079, administered orally, once daily
|
Placebo
n=130 Participants
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Mean Change From Baseline in Body Mass Index (BMI) at Week 12
|
-0.18 kg/m^2
Standard Error 0.07
|
-0.32 kg/m^2
Standard Error 0.09
|
Adverse Events
SCH 497079
Placebo
Serious adverse events
| Measure |
SCH 497079
n=267 participants at risk
SCH 497079, administered orally, once daily
|
Placebo
n=134 participants at risk
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
General disorders
Chest pain
|
0.37%
1/267 • Number of events 1 • 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
|
0.00%
0/134 • 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
|
|
Infections and infestations
Pneumonia
|
0.37%
1/267 • Number of events 1 • 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
|
0.00%
0/134 • 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
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/267 • 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
|
0.75%
1/134 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.37%
1/267 • Number of events 1 • 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
|
0.00%
0/134 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.37%
1/267 • Number of events 1 • 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
|
0.00%
0/134 • 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
|
|
Nervous system disorders
Cerebrovascular accident
|
0.37%
1/267 • Number of events 1 • 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
|
0.00%
0/134 • 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
|
Other adverse events
| Measure |
SCH 497079
n=267 participants at risk
SCH 497079, administered orally, once daily
|
Placebo
n=134 participants at risk
Placebo capsules, administered orally, once daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.1%
35/267 • Number of events 40 • 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
|
0.00%
0/134 • 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
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
14/267 • Number of events 14 • 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
|
5.2%
7/134 • Number of events 7 • 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
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
18/267 • Number of events 19 • 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
|
8.2%
11/134 • Number of events 11 • 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
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
6/267 • Number of events 6 • 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
|
5.2%
7/134 • Number of events 7 • 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
|
|
Nervous system disorders
Dysgeusia
|
6.0%
16/267 • Number of events 16 • 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
|
0.00%
0/134 • 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
|
|
Nervous system disorders
Headache
|
9.0%
24/267 • Number of events 25 • 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
|
0.75%
1/134 • Number of events 1 • 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
|
|
Psychiatric disorders
Anxiety
|
6.7%
18/267 • Number of events 21 • 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
|
0.75%
1/134 • Number of events 1 • 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
|
|
Psychiatric disorders
Insomnia
|
31.1%
83/267 • Number of events 91 • 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
|
0.75%
1/134 • Number of events 1 • 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
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER