Phase 1
Completed N=61
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
Source: ClinicalTrials.gov NCT03041792 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5 — -254.48; -19.93; -278.78; -37.43 kilocalories (kcal) — p=0.0000
Summary
This will be a randomized, double blind, placebo controlled, 2 arm, parallel group, methodology study to assess the effect of 6 weeks of liraglutide administration on food intake in obese subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5 |
-254.48; -19.93; -278.78; -37.43 | 0.0000 sig |
| SECONDARY Number of Participants With Vital Signs Data Meeting Categorical Criteria |
3; 5; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (All-Causality) |
31; 20 | — |
| SECONDARY Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
32; 26 | — |
| SECONDARY Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5 |
-1058.8; -205.64; -1152.5; -242.84 | 0.0000 sig |
| SECONDARY Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5 |
4.52; -0.60; 4.13; -0.99 | 0.0263 sig |
| SECONDARY Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5 |
3.94; -0.55; 4.51; 1.02; 4.04; 1.88 | 0.1768 |
| SECONDARY Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5 |
18.30; -4.55; 81.19; -8.28; 197.79; -12.92 | 0.5008 |
Eligibility Criteria
Inclusion Criteria
- Males and female subjects;
- Body Mass Index 30-40 kg/m2;
Exclusion Criteria
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Data sourced from ClinicalTrials.gov (NCT03041792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.