A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Da… (NCT04615273) | Clinical Trial Compass
CompletedPhase 3
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
United States264 participantsStarted 2020-12-03
Plain-language summary
A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.
Who can participate
Age range23 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age between 23 and 80 years, inclusive, at screening.
✓. Glucagon stimulation test according to body mass index (BMI)
✓. Three or four pituitary axis deficiencies (i.e., adrenal, thyroid, gonadal, and/or vasopressin; not including GH) with insulin-like growth factor-1 standard deviation score (IGF-1 SDS) \<= -2.0 at screening
✓. Macimorelin test: peak GH \<=2.8 ng/mL
✓. Growth hormone releasing hormone (GHRH) + arginine test according to BMI:
✓. Insulin tolerance test: peak GH \<=1.8 ng/mL
Exclusion criteria
✕. Known Prader-Willi Syndrome and/or other genetic diseases that may have an impact on an endpoint.
✕
What they're measuring
1
Change From Baseline in Trunk Percent Fat at Week 38
. Diabetes mellitus at screening if any of the following criteria are met:
✕. Poorly controlled diabetes, defined as HbA1c \>7.5% at screening.
✕. Diabetes mellitus (defined as HbA1c \>=6.5% and/or fasting plasma glucose \>=126 mg/dL and/or plasma glucose \>=200 mg/dL two hours after oral glucose tolerance test) diagnosed \<26 weeks prior to screening
✕. Change in diabetes regimen (includes dose adjustment) within \<90 days prior and throughout screening
✕. Use of any diabetes drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors for a cumulative duration of greater than 4 weeks within 12 months prior to screening
✕. Diabetes-related complications at screening (i.e., nephropathy as judged by the investigator, neuropathy requiring pharmacological treatment, retinopathy stage 2/moderate and above within 90 days prior to screening or during screening)
✕. Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: