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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04883346
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

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 7 study visits....


Condition or disease Intervention/treatment Phase
Obesity Status Post Sleeve Gastrectomy Drug: Liraglutide Phase 2

Detailed Description:

This is an open-label Phase II non-randomized pilot study conducted at the NIH Clinical Center to investigate the efficacy of daily subcutaneous injection of liraglutide, a glucagon-like peptide-1 (GLP1) analogue to promote reduction of body mass index (BMI) in adolescents who continue to have obesity (BMI greater than or equal to 30 or BMI greater than or equal to 95th percentile for age and sex) 1 year or more after vertical sleeve gastrectomy (SG). We hypothesize that administration of liraglutide will be associated with reduction in BMI in such adolescents.

The Primary objective is to determine the effect size for the change in BMI of liraglutide 3.0 mg daily subcutaneously at 16 weeks in adolescents who have obesity after SG, in order to use the observed changes to determine the sample size of a subsequent randomized, controlled investigation. Up to 50 adolescents and young adults (age 12-20) will be recruited to treat up to 40 with liraglutide for 16 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study
Actual Study Start Date : June 21, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
Treated with Liraglutide
Drug: Liraglutide
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.




Primary Outcome Measures :
  1. Change in BMI [ Time Frame: 16 weeks ]
    The change in BMI (kg/m2) measured from the baseline visit to the week 16 visit will be used to inform a power calculation for a subsequent trial.


Secondary Outcome Measures :
  1. Change in Fat Mass [ Time Frame: 16 weeks ]
    Change in fat mass (in kg) from baseline to the week 16 visit

  2. Change in BMI [ Time Frame: 16 weeks ]
    The change in BMI (kg/m2) from baseline to the week 16 visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Male or female, 12-20.999 years at screening visit
  2. 12 months or more status-post vertical sleeve gastrectomy with a maximum of 10 years after surgery
  3. BMI 30 kg/m2 or greater than or equal to 95th percentile for age and sex
  4. In good general health as evidenced by medical history
  5. Ability to take subcutaneous medication and be willing to adhere to the daily subcutaneous liraglutide regimen
  6. Ability to provide consent/assent before any trial-related activities as required per protocol
  7. Stated availability for the duration of the study

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. 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
  2. Weight of more than 450 lbs. (because Dual-Energy X-ray Absorptiometry (DXA) scanning cannot be done in those exceeding this weight)
  3. Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance such as a DPPIV inhibitor
  4. Weight loss of more than 3% of body weight in the past 2 months
  5. Current pregnancy, desire to become pregnant within study period, current lactation or, if sexually active, not willing to use adequate contraceptive measures
  6. History of recurrent pancreatitis (greater than 2 episodes)
  7. History of chronic kidney disease (eGFR <60)
  8. History of gastroparesis
  9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  10. History of prior metabolic and bariatric surgery other than vertical sleeve gastrectomy
  11. Current or prior use of any GLP-1 agonist medication during the 6 months before screening, including liraglutide.
  12. Known or suspected allergy to trial medication, excipients, or related products
  13. Treatment with another investigational drug or other experimental intervention within 3 months prior to enrollment in this trial
  14. 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
  15. Suicidal ideation type 4 or 5, history of past suicide attempt, and suicidal behavior in the past month
  16. Presence of a major medical illness not listed above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883346


Contacts
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Contact: Anna Zenno, M.D. (301) 451-0396 anna.zenno@nih.gov
Contact: Jack A Yanovski, M.D. (301) 496-0858 jy15i@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jack A Yanovski, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional Information:
Publications:
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT04883346    
Other Study ID Numbers: 10000241
000241-CH
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: March 28, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .Individual data for all IPD that underlie results in a publication will be made available.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Children
glucagon-like peptide
Weight Loss
pharmacotherapy for obesity
Bariatric Surgery
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists