SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Novo Nordisk A/S
Study ID
NCT04775082
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. The dose will increase each week over 4 or 5 weeks until the final dose is reached.
  • Placebo — DRUG
    The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.

Study Details

The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects. Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day. In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight. The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.

Key Dates

Start date
Mar 4, 2021
Status verified
May 2026
Primary completion
Aug 1, 2023
Completion
Feb 8, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide 3.0 mg
    The treatment duration is 56 weeks and the follow-up period is 26 weeks.
  • Placebo Comparator: Placebo
    The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Primary Outcome Measure

Relative change in BMI (Body mass index) [ Time Frame: From baseline (week 0) to week 56 ]

Locations (9)

FacilityCityStateZIPSite coordinators
TMC Hlthcr Clin Res OfficeTucsonArizona85712-
Children's Hospital ColoradoDenverColorado80045-
Solaris Clinical ResearchMeridianIdaho83646-
Pennington Biom Res CtrBaton RougeLouisiana70808-
Barry J. Reiner, MD LLCBaltimoreMaryland21229-
University of Minnesota_CPOMMinneapolisMinnesota55414-
UBMD Peds-Div of Endo/DiabetesBuffaloNew York14203-
PriMed Clinical ResearchDaytonOhio45419-
UPMC Child Hosp-PittsburghPittsburghPennsylvania15224-

Related coverage on Hipa.ai

Find similar trials in Tucson, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
TMC Hlthcr Clin Res Office· Tucson, AZChildren's Hospital Colorado· Denver, COSolaris Clinical Research· Meridian, IDPennington Biom Res Ctr· Baton Rouge, LABarry J. Reiner, MD LLC· Baltimore, MDUniversity of Minnesota_CPOM· Minneapolis, MN

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