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ObesityPhase 2NCT04883346

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

A Phase 2 study testing Liraglutide in people with Obesity and Status Post Sleeve Gastrectomy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 20 years
Conditions the study is for
Obesity, Status Post Sleeve Gastrectomy
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
21 Jun 2021to 30 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • 12 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Suicidal ideation type 4 or 5, history of past suicide attempt, and suicidal behavior in the past month
  • Presence of a major medical illness not listed above

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study

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.

Read more

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....

Read the detailed description

Study Description:

This trial 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 (Bullet)30 or BMI >=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.

Objectives:

Primary objective: 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.

Hypothesis:

The Primary Endpoint is estimation of required sample size for a later randomized controlled trial through calculation of effect size for change in body mass index (BMI) from baseline to 16 weeks of liraglutide. The hypothesis is: The data will be sufficient to calculate the effect size for change in BMI from baseline to 16 weeks for a 2-group experiment (placebo versus liraglutide).

Secondary objectives:

To study the effects of 16 weeks of liraglutide 3.0 mg subcutaneously on change in mean BMI and fat mass in adolescents who underwent vertical sleeve gastrectomy (SG) >=1y prior to study initiation but still have obesity or have a recrudescence of obesity despite surgery. To compare the effects of liraglutide on BMI and fat mass in enrolled participants who had a poor initial response to SG (<20% BMI reduction at BMI nadir) vs. those with a typical post-SG weight loss (>=20% BMI reduction at BMI nadir).

Additional Objectives:

To examine the effects of daily subcutaneous liraglutide in enrolled participants on changes in body composition, metabolic syndrome markers, energy intake, glucose tolerance, gastrointestinal (GI)

hormone concentrations, appetite, free living physical activity, mood, suicidality, weight related quality of life, self-perception of body image, and secretome.

Endpoints:

Primary Endpoint: Estimation of required sample size for a later RCT through calculation of effect size for change in body mass index (BMI) from baseline to 16 weeks of liraglutide.

Key Secondary Endpoints:

Changes in BMI and fat mass after 16 weeks of liraglutide Comparison of changes in BMI and fat mass after 16 weeks of liraglutide in participants who had a poor initial response to SG (<20% BMI reduction at BMI nadir) vs. those with a typical post-S weight loss (>=20% BMI reduction at BMI nadir) Tolerability and safety of liraglutide 3.0 mg.

Additional (exploratory) Endpoints: Change from baseline to 16 weeks of liraglutide in:

  1. Proportion reducing BMI by at least 5% and 10%
  2. BMI standard deviation score for age and sex (BMIz)
  3. Body weight
  4. Percentage total body fat mass by DXA
  5. Appetite score using visual analog scale (VAS)
  6. Attention bias to highly palatable images
  7. Energy intake at buffet meal
  8. Free living physical activity by accelerometry
  9. Metabolic syndrome markers (waist circumference, systolic and diastolic blood pressure, lipids, fasting plasma glucose level)
  10. Fasting plasma insulin and HOMA-IR index
  11. 2-hour oral glucose tolerance test (OGTT) insulin and glucose measurements
  12. Hemoglobin A1C
  13. Plasma GI hormones (GLP-1 and PYY) during OGTT
  14. Weight related quality of life (QoL) score
  15. Beck Depression Inventory total score
  16. Body-Esteem Scale Score for Adolescents and Adults
  17. Columbia Suicide Severity Rating Scale
  18. Secretome analysis
  19. Stool microbiome analysis
Being tested
Liraglutide
Keywords
Children, glucagon-like peptide, Weight Loss, pharmacotherapy for obesity, Bariatric Surgery
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Saxenda

    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.

Study groups in NCT04883346
Study groupRoleWhat they receive
LiraglutideExperimentalTreated with Liraglutide
Receives: Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (4)

  1. Change in Fat Mass

    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

    Measured: 16 weeks

  2. Change in BMI

    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

    Measured: 16 weeks

  3. Change in Body Mass Index Z-score

    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.

    Measured: 16 weeks

  4. Change in Body Weight

    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

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start21 Jun 2021
  3. Primary completion15 Mar 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883346
Sponsor's protocol ID
10000241
Other IDs
000241-CH
Status last verified
16 May 2024
First submitted
11 May 2021
Last updated
20 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual data for all IPD that underlie results in a publication will be made available.

Publications

  • 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.

    PubMed 32233338

  • 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.

    PubMed 26132939

  • 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.

    PubMed 26544725

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liraglutide in people with Obesity and Status Post Sleeve Gastrectomy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohen's d (the Standardized Mean Difference) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04883346, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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