At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Enlicitide Decanoate (drug), Placebo (drug)
- How long the study runs
- Study runs about 137 months (dates as stated)
- About the drug or intervention
- Enlicitide Decanoate — drug: Enlicitide decanoate taken by mouth · Placebo — drug: Placebo tablet matched to enlicitide decanoate taken by mouth
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 6 Years to 17 Years
- Who
- All
- Number of participants
- 153
- Started
- 2025-08-21
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for heterozygous familial hypercholesterolemia (hefh)
- • Phase2/Phase3 - 153 participants
- • This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood
Who can take part?
- • Ages 6 Years to 17 Years
- • Diagnosed with heterozygous familial hypercholesterolemia (hefh)
Where?
- • Birmingham - Birmingham Childrens Hospital ( Site 1501)
- • Sheffield - Sheffield Childrens Hospital ( Site 1503)
- • Southampton - Southampton General Hospital ( Site 1502)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood. The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 6 Years - 17 Years
- Who can join: All genders
What the study is looking for
- ✓Inclusion criteria include, but are not limited to:
- ✓Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic...
- ✓Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
- ✓Is receiving either:
- ✓An optimized daily dose of statin (± nonstatin LLT)
Who cannot take part
- ✗Exclusion criteria include, but are not limited to:
- ✗Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH,...
- ✗Has a history of nephrotic syndrome
- ✗Has any clinically significant malabsorption condition based on investigator assessment
- ✗Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein...
See the full criteria
Where Is This Study? (3 UK sites)
Birmingham Childrens Hospital ( Site 1501)
Birmingham B4 6NH, United Kingdom
Sheffield Childrens Hospital ( Site 1503)
Sheffield S10 2TH, United Kingdom
Southampton General Hospital ( Site 1502)
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
