Energy Intake
| Group | Value (kcal/day) | Spread |
|---|---|---|
| Exenatide | 1016.1 | 724.5 |
| Placebo | 245.1 | 710.5 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects
NCT008566093 Mar 2009 to 19 Sept 2016
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Exenatide is an incretin-like drug that has been approved for treatment of type 2 diabetes; it improves glycemia by increasing insulin and decreasing glucagon secretion by pancreatic islet cells and delaying gastric emptying. This randomized, placebo-controlled study is to evaluate whether exenatide over a 5 week period in non-diabetic obese subjects may lead to weight loss. To control for variability in individual response to weight loss treatment, this study will assess the role of exenatide in changing food intake and energy expenditure as possible sources of weight loss. This study will also evaluate the safety profile of exenatide in non-diabetic obese people. Additional assessments will evaluate changes in body fat and hormones involved in the sensations of hunger and fullness.
Active comparator
Exenatide
10 micrograms subcutaneously twice
Placebo comparator
Placebo
Twice daily
Outcomes the sponsor listed as primary.
Energy Intake
Time frame · Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)
Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups
Twenty-four-hour Energy Expenditure
Time frame · Day 5 and Day 11
Change of twenty-four-hour energy expenditure between at Day 5 at baseline assessment and at Day 11 two days after starting study medication between the exenatide and placebo groups
Body Weight
Time frame · 5 weeks
Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (kcal/day) | Spread |
|---|---|---|
| Exenatide | 1016.1 | 724.5 |
| Placebo | 245.1 | 710.5 |
| Group | Value (kcal/day) | Spread |
|---|---|---|
| Exenatide | 51.6 | 157.2 |
| Placebo | 28.9 | 119.7 |
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide | 1.6 | 3.15 |
| Placebo | 0.27 | 2.96 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide10 micrograms subcutaneously twice Byetta (exenatide): Exenatide is an injectable medication Weight loss: Because response to weight loss | 0 / 40 | 0 / 40 | 39 / 40 |
| PlaceboTwice daily Metabolic Chamber: The subject stays in the small room Placebo | 0 / 39 | 0 / 39 | 39 / 39 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
4 studies on this page
Indexing hint: Randomized controlled trial · 2018
Basolo et al. 2018Metabolism: clinical and experimentalcited by 36
PMID 29596853PMC6062468DOI 10.1016/j.metabol.2018.03.017PUB-29596853
Indexing hint: Randomized controlled trial · 2007
Buse et al. 2007Clinical therapeuticscited by 194
PMID 17379054DOI 10.1016/j.clinthera.2007.01.015PUB-17379054
Indexing hint: Meta-analysis (pooled) · 2007
Amori et al. 2007JAMAcited by 755
PMID 17622601DOI 10.1001/jama.298.2.194PUB-17622601
Indexing hint: Randomized controlled trial · 2004
Buse et al. 2004Diabetes carecited by 890
PMID 15504997DOI 10.2337/diacare.27.11.2628PUB-15504997
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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