ObesityPhase 2NCT00642993

Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Participants (Study P05483)(COMPLETED)

A Phase 2 study testing SCH 497079 in people with Obesity and Overweight, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Overweight, Body Weight
What is being tested?: SCH 497079
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 401 participants
Where: No sites listed yet
Study dates: 9 Jun 2008to 30 Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

>= 18 years of age, of either sex, and of any race.
Obese or overweight participants.

Who cannot join

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.

About this study

Official title: A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects

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.

Read the 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.

Conditions: Obesity, Overweight, Body Weight
Being tested: SCH 497079, Placebo
Medical subject headings: Obesity, Overweight, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCH 497079Drug
100 mg capsule administered orally
PlaceboDrug
Placebo capsules matching SCH 497079 administered orally

Study groups in NCT00642993
Study group	Role	What they receive
SCH 497079	Experimental	SCH 497079, administered orally, once daily Receives: Drug: SCH 497079
Placebo	Placebo comparator	Placebo capsules, administered orally, once daily Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 12

Secondary outcomes (4)

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.
Measured: Baseline and Week 12
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.
Measured: 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.
Measured: 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.
Measured: Baeline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 200830 Jan 2009

First posted25 Mar 2008 (estimated)
Study start9 Jun 2008
Primary completion30 Jan 2009
Study completion30 Jan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 401 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00642993
Sponsor's protocol ID: P05483
Other IDs: MK-7079-008
Status last verified: Aug 2018
First submitted: 21 Mar 2008
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Efficacy and Safety Trial to Evaluate the Effect of SCH 497079 on Weight in Obese and Overweight Subjects
ClinicalTrials.gov ID: NCT00642993
Acronym / sponsor ID: P05483
Conditions: Obesity, Overweight, Body Weight
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 401 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 9 Jun 2008 (actual)
Primary completion: 30 Jan 2009 (actual)
Study completion: 30 Jan 2009 (actual)
First posted: 25 Mar 2008 (estimated)
Results: Posted 27 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SCH 497079	Experimental	Drug: SCH 497079SCH 497079, administered orally, once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsules, administered orally, once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

>= 18 years of age, of either sex, and of any race.
Obese or overweight participants.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCH 497079100 mg capsule administered orally	Drug	SCH 497079
PlaceboPlacebo capsules matching SCH 497079 administered orally	Drug	Placebo

Primary outcome

Mean Change From Baseline in Body Weight at Week 12
Time frame: 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.

4 secondary outcomes

Percentage of Participants Demonstrating a Weight Loss ≥5% at Week 12
Time frame: Baseline and Week 12
Percentage of Participants Demonstrating a Weight Loss ≥10% at Week 12
Time frame: Baseline and Week 12
Mean Change From Baseline in Waist Circumference at Week 12
Time frame: Baseline and Week 12
Mean Change From Baseline in Body Mass Index (BMI) at Week 12
Time frame: Baeline and Week 12

Results and safety

Results posted to the registry on 27 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCH 497079	267	161
Placebo	134	118

Primary outcome: Mean Change From Baseline in Body Weight at Week 12

Time frame: Baseline and Week 12. Mean (Standard Error). Unit: Kilogram

Measure	SCH 497079 n = 255	Placebo n = 130
Value	-0.51 (0.19)	-0.92 (0.26)

SCH 497079 vs Placebo: Difference in means: 0.41 (95% CI -0.20 to 1.03), p = 0.187, ANOVA

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCH 497079	5 of 267 (1.9%)	142 of 267 (53.2%)	Not reported
Placebo	1 of 134 (0.7%)	26 of 134 (19.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCH 497079 in people with Obesity and Overweight, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Body Weight at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00642993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.