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Weight LossPhase 3NCT00856609

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

A Phase 3 study testing Byetta (exenatide), Weight loss and Metabolic Chamber in people with Weight Loss and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Weight Loss, Obesity
What is being tested?
Byetta (exenatide), Weight loss and Metabolic Chamber
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteUnited States
Study dates
3 Mar 2009to 19 Sep 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NIDDK, Phoenix

    Phoenix, Arizona, 85014

Other trials in United States

About this study

Official title: The Effects of Exenatide (Byetta) on Energy Expenditure and Weight Loss in Non-Diabetic Obese Subjects

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.

Read the detailed description

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.

Conditions
Weight Loss, Obesity
Being tested
Byetta (exenatide), Weight loss, Metabolic Chamber, Placebo
Keywords
Weight Loss, Byetta (Exenatide), Energy Expenditure, Food Intake, Obesity
Medical subject headings
Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Byetta (exenatide)Drug

    Exenatide is an injectable medication

  • Weight lossBehavioural

    Because response to weight loss

  • Metabolic ChamberOther

    The subject stays in the small room

  • PlaceboDrug

Study groups in NCT00856609
Study groupRoleWhat they receive
ExenatideActive comparator10 micrograms subcutaneously twice
Receives: Drug: Byetta (exenatide); Behavioral: Weight loss
PlaceboPlacebo comparatorTwice daily
Receives: Other: Metabolic Chamber; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)

  2. 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

    Measured: Day 5 and Day 11

Secondary outcomes (1)

  1. Body Weight

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

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2009 (estimated)
  2. Study start3 Mar 2009
  3. Primary completion19 Sep 2016
  4. Study completion19 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856609
Sponsor's protocol ID
999909095
Other IDs
09-DK-N095
Status last verified
19 Jan 2018
First submitted
5 Mar 2009
Last updated
4 Jun 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. 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. Clin Ther. 2007 Jan;29(1):139-53. doi: 10.1016/j.clinthera.2007.01.015.

    PubMed 17379054

  • Buse JB, Henry RR, Han J, Kim DD, Fineman MS, Baron AD; Exenatide-113 Clinical Study Group. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004 Nov;27(11):2628-35. doi: 10.2337/diacare.27.11.2628.

    PubMed 15504997

  • Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007 Jul 11;298(2):194-206. doi: 10.1001/jama.298.2.194.

    PubMed 17622601

  • Hollstein 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.

    PubMed 32002540

  • Stinson 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.

    PubMed 30651576

  • Basolo A, Burkholder J, Osgood K, Graham A, Bundrick S, Frankl J, Piaggi P, Thearle MS, Krakoff J. 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. Metabolism. 2018 Aug;85:116-125. doi: 10.1016/j.metabol.2018.03.017. Epub 2018 Mar 26.

    PubMed 29596853

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Byetta (exenatide), Weight loss and Metabolic Chamber in people with Weight Loss and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Energy Intake (time frame: Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856609, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.

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