Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI

NCT02794402 | Completed Phase 2 DMC

• 1 other identifier: 2015-001628-45
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief Summary

Combat-JUDO (Combating Juvenile Diabetes and Obesity through normalization of beta-cell function) is part of a collaborative project funded by the Seventh Framework Programme of the European Commission aiming to develop innovative therapeutic strategies by increasing pharmacology-based alternatives targeting insulin hypersecretion for the treatment of young obese individuals. The prevalence of childhood obesity is ranging between 5-25% in Europe. The reason behind these alarming figures is mostly a changing environment with a more sedative lifestyle and supply of excess food. However, specific gene mutations have also been linked to obesity and new genes are continuously being discovered. There are very few effective means of intervention in children with obesity available today. Obesity is closely associated with a number of related metabolic diseases and some children with obesity develop the metabolic syndrome at an early stage in life. Individuals with obesity have an increased risk of developing type 2 diabetes mellitus (T2DM) and with the current increase in childhood obesity, some children will develop T2DM already in their adolescent years with huge impact on their long-term health and life expectancy. Lifestyle modification interventions, including behavioural treatment, diet modification and physical activity, are cornerstones of primary and secondary prevention/treatment of pediatric obesity today. Exenatide is a GLP-1 (glucagon-like peptide-1) receptor agonist approved for use in adults with T2DM to improve glycemic control. A pilot study with exenatide treatment in non-diabetic children and adolescents with severe obesity showed a reduced BMI of approximately 5% and improved markers of insulin resistance and β-cell function were observed. The Combat-JUDO study is a parallel, double-blind, randomized study comparing lifestyle intervention + exenatide 2 mg vs lifestyle and intervention + placebo in adolescents with obesity. The lifestyle intervention includes regular nutritional and psychological support at 4 occasions during the study as well as physical activity on a weekly basis. Exenatide/placebo is given as a subcutaneous injection once weekly for 24 weeks. The primary objective of the study is to compare the change in BMI-SDS (according to WHO) from baseline to the 6 months visit between the two treatment arms. The study includes males and females of age 10-18 years and 5 months with BMI SDS \>2.0 or age-adapted BMI \>30 kg/m2.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• BMI SDS (Body Mass Index Standard Deviation Score)

  The primary objective is to compare the change from baseline to the 6 months visit, between lifestyle intervention + exenatide 2 mg once weekly and lifestyle intervention + placebo, in BMI SDS (according to WHO) for adolescents with obesity.

  6 months

Study Arms (2)

Bydureon

ACTIVE COMPARATOR

s.c. once Weekly

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

s.c. once Weekly

Behavioral: Placebo

Interventions

Exenatide DRUG

Bydureon (Exenatide once weekly) injections s.c.

Bydureon

Placebo BEHAVIORAL

Placebo once weekly injections sc

Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent prior to any study-specific procedures.
• Males or females of age 10-18 years and 5 months.
• Obesity (BMI SDS \> 2.0 or age-adapted BMI \> 30 kg/m2), according to WHO.
• Not sexually active or usage of adequate anticonception. Female subjects must also have negative pregnancy tests. Methods that can achieve a failure rate of less than 1% per year (Pearl index \<1), when used consistently and correctly, are considered as highly effective birth control methods. Such methods include:
• Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• oral
• intravaginal
• transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:
• oral
• injectable
• implantable
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion

You may not qualify if:

• Known syndromal obesity, such as Prader-Willi syndrome, Laurence-Moon syndrome or Bardet-Biedl syndrome.
• Pregnancy or lactation.
• Indigestion-causing diseases.
• Severe gastrointestinal disease.
• Total or partial gastric or small intestine resection.
• Type 1 or Type 2 diabetes mellitus.
• Kidney disease (acute or chronic, according to physician (Creatinin/Urea/Cystatin-C for Schwartz Calculation)).
• Hypo-/Hyperthyroidism, unless under stable treatment.
• Severe Vitamin D insufficiency, unless under stable treatment.
• Abnormal QT interval.
• Clinically significant abnormal laboratory values, e.g. Triglycerides \> 400 mg/dl (Salzburg) or \> 4,5 mmol/L (Uppsala), Amylase \> 300 U/L (Salzburg) or \> 5,1 µkat/L (Uppsala), Lipase \> 180 U/L (Salzburg) or \> 15 µkat/L (Uppsala) or Calcitonin \> 11.7 pg/ml (Salzburg) or \> 3,4 pmol/L (Uppsala) for females and \> 17 pg/ml (Salzburg) or \> 5,0 pmol/L (Uppsala) for males.
• Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by the investigator.
• Severe sleep apnea (defined clinically).
• Chronic diseases, as judged by the investigator.
• Metformin treatment within 3 months prior to screening or concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (2)

Department of Pediatrics, Salzburg State Hospital, Paracelsus Medical University

Salzburg, 5020, Austria

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (1)

• Stenlid R, Cerenius SY, Wen Q, Aydin BK, Manell H, Chowdhury A, Kristinsson H, Ciba I, Gjessing ES, Morwald K, Gomahr J, Heu V, Weghuber D, Forslund A, Bergsten P. Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control. Front Endocrinol (Lausanne). 2023 Nov 1;14:1293093. doi: 10.3389/fendo.2023.1293093. eCollection 2023.

  PMID: 38027106 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exenatide

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

Study Officials

• Anders Forslund, Assoc Prof

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 9, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

SE (1); AU (1)