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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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....

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Liraglutide

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