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 States, Armenia, Australia264 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 range
23 Years – 80 Years
Sex
ALL
See this in plain English?
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Trunk Percent Fat at Week 38
. Known Prader-Willi Syndrome and/or other genetic diseases that may have an impact on an endpoint.
. 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: