Exenatide in Extreme Pediatric Obesity

NCT01237197 | Completed Phase 2 Results DMC

• 1 other identifier: 1009M88952
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss have been evaluated in adolescents. Since exenatide is associated with weight loss and improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be useful in extremely obese youth. Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an innovative approach to a challenging and significant health care problem.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Mass Index at 3-months

  As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.

  Baseline and 3-months

Study Arms (2)

Exenatide, then Open-Label Exenatide

EXPERIMENTAL

Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)

Drug: Exenatide

Placebo, then Open Label Exenatide

PLACEBO COMPARATOR

Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.

Drug: Exenatide; Drug: Placebo

Interventions

Exenatide DRUG

Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.

Also known as: Byetta

Exenatide, then Open-Label Exenatide; Placebo, then Open Label Exenatide

Placebo DRUG

Participants were randomized to a placebo injection for the first three months, then given open-label Exenatide for the remaining three months (Initiated at 5 mcg, twice per day, delivered by subcutaneous injection. After 1 month, exenatide was uptitrated to 10 mcg, twice per day for the remaining 2 months of the drug treatment phase).

Also known as: Sugar pill

Placebo, then Open Label Exenatide

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Body mass index \> or = 1.2 times the 95th percentile (based on gender and age) or Body mass index \> or = 35 kg/m2
• years old

You may not qualify if:

• Type 1 or 2 diabetes mellitus
• Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)
• Previous bariatric surgery
• Recent initiation (within 1-month) of anti-hypertensive or lipid medication
• Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
• Major psychiatric disorder
• Pregnant or planning to become pregnant
• Tobacco use
• Liver/renal dysfunction
• History of pancreatitis
• Obesity associated with genetic disorder
• Hyperthyroidism or uncontrolled hypothyroidism
• Uncontrolled hypertriglyceridemia (=300 mg/dL)
• Current eating disorder
• Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)

Sponsors & Collaborators

• University of Minnesota: lead
• Children's Hospitals and Clinics of Minnesota: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Related Publications (1)

• Kelly AS, Rudser KD, Nathan BM, Fox CK, Metzig AM, Coombes BJ, Fitch AK, Bomberg EM, Abuzzahab MJ. The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial. JAMA Pediatr. 2013 Apr;167(4):355-60. doi: 10.1001/jamapediatrics.2013.1045.

  PMID: 23380890 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exenatide; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Aaron S. Kelly, Ph.D.
• Organization: University of Minnesota

kelly105@umn.edu

612-626-3492

Study Officials

• Aaron S. Kelly, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

US (2)