Primary outcome
What NCT03374956 measured first
| Intervention Groupn=93 | Control Groupn=100 |
|---|---|
| -7.7(-11 to -4.7) | -6.5(-11 to -2.3) |
Phase 3 · Liraglutide
NCT03374956 trial results
Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial
Change in Total Body Weight (percent change), baseline to 12 weeks. Intervention Group: -7.7; Control Group: -6.5.
- Participants
- 193
- Status
- completed
- Completed
- 2022-05-26
- Sponsor
- Mayo Clinic
As posted on ClinicalTrials.gov (NCT03374956), updated at source Jul 18, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT03374956
Percent of participants affected, Baseline to 12 months. The most common events the registry lists.
| Event | Intervention Group | Control Group |
|---|---|---|
| Any serious event | 0% | 0% |
| During study | 24.7% | 25% |
Secondary outcomes
What else it measured
| Intervention Groupn=93 | Control Groupn=100 |
|---|---|
| 81 | 80 |
| Intervention Groupn=93 | Control Groupn=100 |
|---|---|
| 44 | 40 |
The trial
How NCT03374956 was run
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
- Intervention group: Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
- Control Group: Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Who could join the trial
Inclusion criteria: * Adults with obesity (BMI \>30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases. * Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. Exclusion criteria * Abdominal bariatric surgery * Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months. * Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. * Hypersensitivity to any of the study medications. * No contraindications to all FDA-approved medications
Published papers
Papers from NCT03374956
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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