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NCT02911818 · ClinicalTrials.gov registry record · Phase 4
Lifestyle Modification and Liraglutide
A Phase 4 study of Obesity, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT02911818: Completed Phase 4 study of Obesity, sponsored by University of Pennsylvania.
NCT02911818 is a Phase 4 study of Obesity that has completed, run by University of Pennsylvania. The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02911818, a Phase 4 study of Obesity, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention). Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration of counseling visits recommended by CMS. Counseling sessions will be delivered by a physician, nurse practitioner or registered dietitian (RD) working in consultation with the former providers. Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide groups to monitor their response to the medication. These visits are included for subjects in CMS-Alone to match the intensity of medical care provided the two other groups. The primary outcome is % reduction in initial body weight, as measured from randomization to week 52. Secondary outcomes include the proportion of participants who at week 52 lose \>5%, \>10%, and \>15% of initial weight, as well as % reduction in weight at week 24 and the proportion of participants who meet the three categorical weight losses at this time. The secondary efficacy measures include changes (from randomization to week 52) in cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior, appetite, sleep, and satisfaction with weight loss. Safety endpoints will include physical examination, adverse events (AEs), standard laboratory tests, and mental health
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- BEHAVIORAL CMS-recommended lifestyle counseling
- DRUG Liraglutide 3.0mg
- OTHER Portion-Controlled Diet
- DRUG Phentermine 15 MG
Study Locations (1)
Pennsylvania
- University of Pennsylvania Center for Weight and Eating Disorders - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2016-09 |
| Est. Completion | 2018-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02911818
The ClinicalTrials.gov registry entry for NCT02911818 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 5 interventions - of which Placebo Oral Tablet is the first listed.
NCT02911818 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02911818 about?
NCT02911818 is a clinical study titled "Lifestyle Modification and Liraglutide". This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently r...
What is the current status of trial NCT02911818?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2016-09. Estimated completion is 2018-12.
What conditions does trial NCT02911818 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT02911818?
The interventions under investigation include: Placebo Oral Tablet (DRUG), CMS-recommended lifestyle counseling (BEHAVIORAL), Liraglutide 3.0mg (DRUG), Portion-Controlled Diet (OTHER), Phentermine 15 MG (DRUG).
Who is sponsoring clinical trial NCT02911818?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02911818 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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