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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT04883346 (opens ClinicalTrials.gov in a new tab)Other id10000241Other id000241-CH

Overview

Status
Completed
Phase
Phase 2
Enrollment
34 participants (actual)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Nih
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
21 Jun 2021
Primary completion
15 Mar 2024
Completion
30 Apr 2024
First posted
12 May 2021
Last update posted
20 Nov 2024
Conditions
Obesity · Status Post Sleeve Gastrectomy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. Ph 2

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

    NCT04883346

    21 Jun 2021 to 30 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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....

Interventions

  • LiraglutideDrug

Arms1

  • Experimental

    Liraglutide

    Treated with Liraglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cohen's d (the Standardized Mean Difference)

    Time frame · 16 weeks

    Registry description

    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.

Secondary outcomes(4)
  1. Change in Fat Mass

    Time frame · 16 weeks

    Registry description

    Change in fat mass (in kg) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing

  2. Change in BMI

    Time frame · 16 weeks

    Registry description

    The change in BMI (kg/m2) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing

  3. Change in Body Mass Index Z-score

    Time frame · 16 weeks

    Registry description

    The change in Body Mass Index Z-score (standard deviation score for age and sex based on US Centers for Disease Control Standards from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing. Please see description for Body Mass Index Z-score in baseline information section for more details on calculation of Body Mass Index Z-score.

  4. Change in Body Weight

    Time frame · 16 weeks

    Registry description

    The change in body weight (kg) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 16 weeks

Cohen's d (the Standardized Mean Difference)

GroupValue (cohen's d)
Liraglutide2.145
Secondary and other outcome results(4)
Secondary outcomeMean· 16 weeks

Change in Fat Mass

GroupValue (kg)Spread
Liraglutide-3.23.4
Secondary outcomeMean· 16 weeks

Change in BMI

GroupValue (kg/m2)Spread
Liraglutide-1.71.5
Secondary outcomeMean· 16 weeks

Change in Body Mass Index Z-score

GroupValue (Z-score)Spread
Liraglutide-0.20.1
Secondary outcomeMean· 16 weeks

Change in Body Weight

GroupValue (kg)Spread
Liraglutide-4.44.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideTreated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose was initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.0 / 340 / 3419 / 34

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

11 results

A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.

Kelly et al. 2020The New England journal of medicinecited by 520

PMID 32233338DOI 10.1056/nejmoa1916038PUB-32233338

Full text at the publisher11 results

Indexing hint: Randomized controlled trial · 2015

6 results

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.

Pi-Sunyer et al. 2015The New England journal of medicinecited by 1,954

PMID 26132939DOI 10.1056/nejmoa1411892PUB-26132939

Rights unknown6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* 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

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