NEAT (Neuroimaging: Emotions and Appetite Testing) Study
The NEAT Study is about obesity, appetite, emotions, and how the brain develops in children. The study team is looking for volunteer youth to participate who are either healthy or have a clinical condition called Congenital Adrenal Hyperplasia (CAH).
Effects of Androgen Excess on Lipid Distribution in Congenital Adrenal Hyperplasia
The aim of this project is to delineate androgen effects on regional adipose depots and ectopic fat non-invasively by magnetic resonance (MR)-based imaging techniques in youth with Congenital Adrenal Hyperplasia (CAH).
Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NBI-74788 versus placebo administered bid with breakfast and the evening meal (doses separated by approximately 12 hours) for 24 weeks in approximately 165 adult subjects with classic CAH due to 21-hydroxylase deficiency.
Neurocrine Ped Study
This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered twice daily (bid) with breakfast and evening meals for28 weeks in approximately 81 pediatric subjects with classic congenital adrenal hyperplasia (CAH) due to21-hydroxylase deficiency. Eligible subjects will be randomly assigned in a 2:1 ratio (active:placebo) to either crinecerfont (25 mg bid via oral solution for subjects 10 to <20 kg, 50 mg bid via oral solution for subjects 20 to <55 kg, or 100 mg bid via oral capsules for subjects ≥55 kg) or matching placebo (oral solution placebo for subjects <55 kg and oral capsule placebo for subjects ≥55 kg). Dose assignment from Day 1 to Week 28 will be based on the subject’s weight at Day 1. After the 28-week placebo-controlled treatment period, there will be a 24-week, open-label treatment period, during which all subjects will receive crinecerfont at doses based on their Week 28 body weight.
Spruce Adult Study
This is a randomized, double-blind, placebo-controlled study that will evaluate the potential of tildacerfont to reduce GC burden in adult subjects with classic CAH who have LLD ≤ A4 ≤ 2.5x ULN and are on supraphysiologic doses of GC therapy (≥30 mg/day and ≤60 mg/day HCe). This will be the first study of tildacerfont to evaluate GC dose reduction. In addition, this study will characterize clinical outcomes after up to 76 weeks of treatment with tildacerfont. An optional Open-Label Extension Period will provide an open-label treatment with tildacerfont at 200 mg QD for up to 240 weeks.
Diurnal Study
This study is a randomized, double-blind, active-controlled, titrated, parallel arm, multicenter study. It will compare the efficacy, safety and tolerability of twice daily Chronocort with twice daily IRHC (Cortef®) over a randomized treatment period of up to 52 weeks in participants aged 16 years and over with known classic CAH due to 21-hydroxylase deficiency. The primary efficacy assessment of biochemical responder rate and the key secondary assessments of dose responder rate and mean total daily dose will be assessed after 52 weeks of randomized treatment.
Food Choices in Type I Diabetes
Evaluate food choices in patients with Type 1 diabetes.
Best Starts in CAH (Congenital Adrenal Hyperplasia)
This prospective, longitudinal study aims to measure and describe the amount and frequency of physical activity, feeding, and sleeping across days and months in infancy.
Food Choices in Type 2 Diabetes
Food Choices in patients with Type 2 Diabetes.
MRI of Congenital Adrenal Hyperplasia (CAH) Youth
Body Composition in Newborns with MRI of Congenital Adrenal Hyperplasia (CAH).