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Trial · Interventional

CompletedPhase 3Results postedRegistry data

The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

NCTNCT00856609 (opens ClinicalTrials.gov in a new tab)Other id999909095Other id09-DK-N095

Overview

Status
Completed
Phase
Phase 3
Enrollment
150 participants (actual)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Nih
Design
Randomized · Double masking
Countries
1 country

United States

Start
3 Mar 2009
Primary completion
19 Sept 2016
Completion
19 Sept 2016
First posted
6 Mar 2009 (estimated)
Last update posted
4 Jun 2019
Conditions
Weight Loss · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201220142016
  1. Ph 3

    The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

    NCT00856609

    3 Mar 2009 to 19 Sept 2016

Registry summary

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.

Interventions

  • Byetta (exenatide)Drug
  • Weight lossBehavioral
  • Metabolic ChamberOther
  • PlaceboDrug

Arms2

  • Active comparator

    Exenatide

    10 micrograms subcutaneously twice

  • Placebo comparator

    Placebo

    Twice daily

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Energy Intake

    Time frame · Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)

    Registry description

    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

  2. Twenty-four-hour Energy Expenditure

    Time frame · Day 5 and Day 11

    Registry description

    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

Secondary outcomes(1)
  1. Body Weight

    Time frame · 5 weeks

    Registry description

    Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)

Energy Intake

GroupValue (kcal/day)Spread
Exenatide1016.1724.5
Placebo245.1710.5
Primary outcomeMean· Day 5 and Day 11

Twenty-four-hour Energy Expenditure

GroupValue (kcal/day)Spread
Exenatide51.6157.2
Placebo28.9119.7
Secondary and other outcome results(1)
Secondary outcomeMean· 5 weeks

Body Weight

GroupValue (kg)Spread
Exenatide1.63.15
Placebo0.272.96

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide10 micrograms subcutaneously twice Byetta (exenatide): Exenatide is an injectable medication Weight loss: Because response to weight loss0 / 400 / 4039 / 40
PlaceboTwice daily Metabolic Chamber: The subject stays in the small room Placebo0 / 390 / 3939 / 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

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2018

11 results

Exenatide has a pronounced effect on energy intake but not energy expenditure in non-diabetic subjects with obesity: A randomized, double-blind, placebo-controlled trial.

Basolo et al. 2018Metabolism: clinical and experimentalcited by 36

PMID 29596853PMC6062468DOI 10.1016/j.metabol.2018.03.017PUB-29596853

Rights unknown11 results

Indexing hint: Randomized controlled trial · 2007

13 results

Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.

Buse et al. 2007Clinical therapeuticscited by 194

PMID 17379054DOI 10.1016/j.clinthera.2007.01.015PUB-17379054

Full text at the publisher13 results

Indexing hint: Meta-analysis (pooled) · 2007

6 results

Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis.

Amori et al. 2007JAMAcited by 755

PMID 17622601DOI 10.1001/jama.298.2.194PUB-17622601

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2004

8 results

Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes.

Buse et al. 2004Diabetes carecited by 890

PMID 15504997DOI 10.2337/diacare.27.11.2628PUB-15504997

Full text at the publisher8 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHollstein T, Basolo A, Ando T, Votruba SB, Krakoff J, Piaggi P. Urinary Norepinephrine Is a Metabolic Determinant of 24-Hour Energy Expenditure and Sleeping Metabolic Rate in Adult Humans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1145-56. doi: 10.1210/clinem/dgaa047. PMID 32002540
  • DerivedStinson EJ, Graham AL, Thearle MS, Gluck ME, Krakoff J, Piaggi P. Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure. Int J Obes (Lond). 2019 Jul;43(7):1456-1465. doi: 10.1038/s41366-018-0305-9. Epub 2019 Jan 16. PMID 30651576

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA: * Premenopausal women and men \< 55 years of age * BMI \>30 kg/m(2) * Expressed desire for weight loss * Stable weight (variation \< 2.3 kg within past 6 months) * Ability to provide informed consent * Ability to follow verbal and written instructions * Nonsmoker * Ability to commute to study site on a regular basis for short outpatient visits over 5 weeks * For females, use of a medically approved form of contraception. For oral contraceptives, subjects will need to be on an established dose for at least 3 months to ensure stable weight and will be asked not to switch contraceptive methods during study participation. EXCLUSION CRITERIA: * Age \< 18 years * Use of other medications to treat obesity including medications obtained over the counter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), topiramate (with or without phentermine (Qsymia), phentermine (Adipex P) or lorcaserin (Belviq) within the past 6 months * History of an eating disorder including anorexia or bulimia * History of surgery for the treatment of obesity (gastric banding, gastric bypass) * Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association guidelines * Previous exposure to exenatide * Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or more occasions or use of antihypertensive medications which may affect energy expenditure including alpha blockers, beta blockers, angiotensin receptor blockers or inhibitors of angiotensin converting enzyme * Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous drug use * Chronic ethanol use (\> 3 drinks /day) * Endocrine disorders including hypo or hyperthyroidism (including subclinical disease), Cushing s disease, growth hormone deficiency or other pituitary diseases * History of pancreatitis * Personal or family history of multiple endocrine neoplasia (MEN)-2 or medullary thyroid cancer * History of unresolved gallstones * Hyperamylasemia * Fasting triglyceride level greater than or equal to 500 * Gastroparesis * Inflammatory bowel disease or malabsorption disorders * Malignancy treated with chemotherapy or radiation within the past 5 years * Current clinical depression, diagnosis of psychosis or recent use of psychotropic medication * Pregnancy within past 6 months * Breastfeeding * Failure to use medically approved contraceptive methods if subject is female * Liver function abnormalities (transaminases greater than twice normal) * Renal insufficiency (creatinine clearance \< 50 ml/min) * History of chronic infection including tuberculosis, coccidiomycoses, lyme disease or HIV infection * Pulmonary disorders, including chronic obstructive pulmonary disease, which would limit ability to follow the protocol (investigator judgment) * Cardiovascular disease including history of myocardial infarction, unstable angina or heart failure * Central nervous system disease, including history of cerebrovascular accidents, dementia, and neurodegenerative disorders * Weight \<450 pounds (maximum weight of the DXA machine as per manufacturer s manual) * Sensitivity to exenatide or any inert components in its formulation * Sensitivity to acetaminophen * Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators

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