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

NCT00856609 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 99990909509-DK-N095
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Weight Loss; Obesity

Keywords

Weight Loss; Byetta (Exenatide); Energy Expenditure; Food Intake; Obesity

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 5 and Day 11

Secondary Outcomes (1)

• Body Weight

  5 weeks

Study Arms (2)

Exenatide

ACTIVE COMPARATOR

10 micrograms subcutaneously twice

Drug: Byetta (exenatide); Behavioral: Weight loss

Placebo

PLACEBO COMPARATOR

Twice daily

Other: Metabolic Chamber; Drug: Placebo

Interventions

Byetta (exenatide) DRUG

Exenatide is an injectable medication

Exenatide

Weight loss BEHAVIORAL

Because response to weight loss

Exenatide

Metabolic Chamber OTHER

The subject stays in the small room

Placebo

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (6)

• 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.

  PMID: 17379054 BACKGROUND

• 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.

  PMID: 15504997 BACKGROUND

• 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.

  PMID: 17622601 BACKGROUND

• 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.

  PMID: 32002540 DERIVED

• 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.

  PMID: 30651576 DERIVED

• 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.

  PMID: 29596853 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Jonathan Krakoff
• Organization: National Institutes of Health

jkrakoff@mail.nih.gov

602-200-5217

Study Officials

• Jonathan Krakoff, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: March 3, 2009
• Primary Completion: September 19, 2016
• Study Completion: September 19, 2016
• Last Updated: June 4, 2019
• Results First Posted: January 12, 2018

Record last verified: 2018-01-19

Locations

US (1)