Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy

NCT04883346 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 10000241000241-CH
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Metabolic Bariatric Surgery, including a surgery called vertical sleeve gastrectomy, is the most effective weight loss treatment for severe obesity. However, many adolescents who have this surgery still have obesity 1 year later or regain weight. Researchers want to see if a drug can help. Objective: To learn if liraglutide can help adolescents who still have obesity 1 year or more after vertical sleeve gastrectomy lose additional weight. Eligibility: Healthy adolescents ages 12-20.99 years who are 1-10 years post vertical sleeve gastrectomy and have a BMI of 30 kg/m2 or \>=95th percentile for age and sex. Design: Participants will be screened with: Medical history Physical exam Questionnaires about their mood and feelings about their weight Blood and urine tests Nutrition counseling. They will keep a diet log. A test where they view and respond to pictures of food Wrist accelerometer set-up. They will wear an accelerometer (a device like a watch) on their wrist for 14 days. It will measure their physical activity. Some screening tests will be repeated during the study. Participants will have an oral glucose tolerance test. They will ingest a sweet liquid. Blood samples will be taken. Participants will take liraglutide daily for 16 weeks. They will learn how to inject it under their skin. Participants will have a body scan to measure muscle and fat. Participants will be invited to eat as much as they want at a buffet meal at NIH. How much food they eat will be calculated. They will assess their appetite and mood before and after the meal. Participation will last for 7 months. Participants will have up to 7 study visits....

Conditions

Obesity; Status Post Sleeve Gastrectomy

Keywords

Children; glucagon-like peptide; Weight Loss; pharmacotherapy for obesity; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• Cohen's d (the Standardized Mean Difference)

  The change in BMI (kg/m2) measured from the baseline visit to the week 16 visit was used to inform a power calculation for a subsequent randomized controlled trial, assuming no change in BMI for the placebo group and the change in BMI that was found in this study at 16 weeks for the liraglutide group. There is no statistical analysis associated with this result.

  16 weeks

Secondary Outcomes (4)

• Change in Fat Mass

  16 weeks

• Change in BMI

  16 weeks

• Change in Body Mass Index Z-score

  16 weeks

• Change in Body Weight

  16 weeks

Study Arms (1)

Liraglutide

EXPERIMENTAL

Treated with Liraglutide

Drug: Liraglutide

Interventions

Liraglutide DRUG

Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.

Also known as: Saxenda

Liraglutide

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Male or female, 12-20.999 years at screening visit
• months or more status-post vertical sleeve gastrectomy with a maximum of 10 years after surgery
• BMI 30 kg/m2 or greater than or equal to 95th percentile for age and sex
• In good general health as evidenced by medical history
• Ability to take subcutaneous medication and be willing to adhere to the daily subcutaneous liraglutide regimen
• Ability to provide consent/assent before any trial-related activities as required per protocol
• Stated availability for the duration of the study

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Current or recent (within 3 months of start of study drug initiation) use of weight loss medications such as phentermine, topiramate, lisdexamfetamine (prescribed specifically for weight loss; when prescribed for ADHD and dose is stable for last 3 months this medication will be allowed), orlistat, and naltrexone HCl/bupropion HCl, or liraglutide
• Weight of more than 450 lbs. (because Dual-Energy X-ray Absorptiometry (DXA) scanning cannot be done in those exceeding this weight)
• Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance such as a DPPIV inhibitor
• Weight loss of more than 3% of body weight in the past 2 months
• Current pregnancy, desire to become pregnant within study period, current lactation or, if sexually active, not willing to use adequate contraceptive measures
• History of recurrent pancreatitis (greater than 2 episodes)
• History of chronic kidney disease (eGFR \<60)
• History of gastroparesis
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• History of prior metabolic and bariatric surgery other than vertical sleeve gastrectomy
• Current or prior use of any GLP-1 agonist medication during the 6 months before screening, including liraglutide.
• Known or suspected allergy to trial medication, excipients, or related products
• Treatment with another investigational drug or other experimental intervention within 3 months prior to enrollment in this trial
• Individuals who have current substance abuse or a DSM 5 Axis I psychiatric disorder or DSM Axis II Mental Retardation diagnosis that in the opinion of the investigators would impede competence, compliance, or participation in the study

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31.

  PMID: 32233338 BACKGROUND

• Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

  PMID: 26132939 BACKGROUND

• Inge TH, Courcoulas AP, Jenkins TM, Michalsky MP, Helmrath MA, Brandt ML, Harmon CM, Zeller MH, Chen MK, Xanthakos SA, Horlick M, Buncher CR; Teen-LABS Consortium. Weight Loss and Health Status 3 Years after Bariatric Surgery in Adolescents. N Engl J Med. 2016 Jan 14;374(2):113-23. doi: 10.1056/NEJMoa1506699. Epub 2015 Nov 6.

  PMID: 26544725 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Jack A. Yanovski, MD, PhD
• Organization: Section on Growth and Obesity, NICHD, NIH

yanovskj@mail.nih.gov

301-496-0858

Study Officials

• Jack A Yanovski, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 12, 2021
• Study Start: June 21, 2021
• Primary Completion: March 15, 2024
• Study Completion: April 30, 2024
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-05-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available starting 6 months after publication or after 1 year following study closure.
• Access Criteria: Data will be stored in NIH CTDB and will be made available to university-based researchers on reasonable request to the Principal Investigator following establishment of a data sharing agreement. Afterwards, the data will be deidentified and transferred to DASH

Locations

US (1)