A Phase 3 interventional study of Byetta (exenatide) and Weight loss in Weight Loss and Obesity, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Treatment
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.
Obesity can lead to a number of health problems including diabetes, heart disease, stroke, low back pain, fatty liver disease, and osteoarthritis. The medical treatments currently available for obesity are limited. Exenatide is an injectable medication approved for treatment of type 2 diabetes that causes weight loss in some diabetic subjects. The reasons exenatide is thought to cause weight loss include decreased food intake, increased feelings of fullness and nausea. Because levels of a human gut hormone (glucagon like peptide 1) that is similar to exenatide have been shown to be related to resting energy expenditure, it is also possible that exenatide may have effects on a person s metabolism, a.k.a. energy expenditure, but any effect of exenatide on energy expenditure has yet to be evaluated. Even though exenatide is used to treat diabetes, administration of exenatide to non-diabetic lean individuals did not cause frankly low blood sugars.
The primary goal of this study is to investigate the way in which exenatide given twice a day to obese (BMI >= 30 kg/m\^2) people without diabetes might lead to weight loss. Because response to weight loss treatment can be highly variable between individuals, we will look at the role of exenatide in changing food intake and energy expenditure as possible explanations for weight loss. We will also assess the safety profile of exenatide in non-diabetic obese people.
This study will involve the use of exenatide or placebo, determined randomly, in obese individuals without diabetes over a 5 week period. The primary measurements will include effects of exenatide on energy expenditure and food intake. We will also look at changes in body fat and the levels of hormones involved in the sensations of hunger and fullness. We will assess if any exenatide-induced changes can predict which individuals lose weight over the 5 weeks. The safety and side effects of exenatide in non-diabetic individuals during this time will also be determined. Findings from this study would help to determine how exenatide works to cause weight loss in people without diabetes, who might benefit most, and would help to improve understanding of why some people respond better to weight loss treatment than others.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 150 is above the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
10 micrograms subcutaneously twice
Drug: Byetta (exenatide) · Behavioral: Weight loss
Twice daily
Other: Metabolic Chamber · Drug: Placebo
Exenatide is an injectable medication
Because response to weight loss
The subject stays in the small room
Energy Intake
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
Time frame: Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)
Twenty-four-hour Energy Expenditure
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
Time frame: Day 5 and Day 11
Body Weight
Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.
Time frame: 5 weeks
| Milestone | Exenatide | Placebo |
|---|---|---|
| Started | 41 | 39 |
| Completed | 40 | 39 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
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
| kcal/day | Exenatide | Placebo |
|---|---|---|
| Energy Intake | 1016.1 ± 724.5 | 245.1 ± 710.5 |
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
| kcal/day | Exenatide | Placebo |
|---|---|---|
| Twenty-four-hour Energy Expenditure | 51.6 ± 157.2 | 28.9 ± 119.7 |
Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.
| kg | Exenatide | Placebo |
|---|---|---|
| Body Weight | 1.6 ± 3.15 | 0.27 ± 2.96 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exenatide | 0/40 (0%) | 0/40 (0%) | 39/40 (97.5%) |
| Placebo | 0/39 (0%) | 0/39 (0%) | 39/39 (100%) |
| Event | Exenatide | Placebo |
|---|---|---|
| hunger decreaseMetabolism and nutrition disorders | 39/40 | 4/39 |
| NauseaGastrointestinal disorders | 24/40 | 19/39 |
| HeadacheGeneral disorders | 23/40 | 21/39 |
| DiarrheaGastrointestinal disorders | 16/40 | 16/39 |
| Gastroesophageal refluxGastrointestinal disorders | 13/40 | 15/39 |
| ConstipationGastrointestinal disorders | 14/40 | 9/39 |
| Injection site reactionProduct Issues | 13/40 | 5/39 |
| ItchinessSkin and subcutaneous tissue disorders | 12/40 | 4/39 |
| VomitingGastrointestinal disorders | 11/40 | 8/39 |
| hypoglycemiaEndocrine disorders | 10/40 | 3/39 |
| Age, Continuous(years) | Exenatide | Placebo | Total |
|---|---|---|---|
| Mean | 35.1 ± 8.4 | 33.7 ± 9.0 | 34.4 ± 8.7 |
| Sex: Female, Male(Participants) | Exenatide | Placebo | Total |
|---|---|---|---|
| Female | 23 | 23 | 46 |
| Male | 17 | 16 | 33 |
| Race/Ethnicity, Customized(Participants) | Exenatide | Placebo | Total |
|---|---|---|---|
| African American | 1 | 9 | 10 |
| White | 11 | 10 | 21 |
| Hispanic | 4 | 6 | 10 |
| Native American | 22 | 14 | 36 |
| Other | 2 | 0 | 2 |
| Body weight(kg) | Exenatide | Placebo | Total |
|---|---|---|---|
| Mean | 105.5 ± 19.2 | 108.8 ± 20.7 | 107.1 ± 19.9 |
| Body Mass Index(kg/m^2) | Exenatide | Placebo | Total |
|---|---|---|---|
| Mean | 38.0 ± 6.6 | 38.2 ± 6.8 | 38.1 ± 6.7 |
| Fat free mass(Kg) | Exenatide | Placebo | Total |
|---|---|---|---|
| Mean | 34.6 ± 11.5 | 37.9 ± 8.7 | 36.3 ± 12.8 |
| Fat mass(Kg) | Exenatide | Placebo | Total |
|---|---|---|---|
| Mean | 27.9 ± 8.8 | 30.8 ± 8.7 | 29.4 ± 8.8 |
| Body fat(percent) | Exenatide | Placebo | Total |
|---|---|---|---|
| Mean | 44.0 ± 6.9 | 44.4 ± 8.7 | 44.2 ± 7.8 |
15 further baseline measures are reported on the registry.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)