Trials / Completed
CompletedNCT04615273
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
foresiGHt: A Multicenter, Randomized, Parallel-arm, Placebo-controlled (Double- Blind) and Active-controlled (Open-label) Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Ascendis Pharma Endocrinology Division A/S · Industry
- Sex
- All
- Age
- 23 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lonapegsomatropin | Due to the different human growth hormone (hGH) dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose. |
| OTHER | Placebo | The placebo for lonapegsomatropin drug product contained the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution was administered by subcutaneous (SC) injection via syringe and needle. Due to the different hGH dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo received the same dose volume as if they were randomized to once-weekly lonapegsomatropin. |
| DRUG | Somatropin | Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose. |
Timeline
- Start date
- 2020-12-03
- Primary completion
- 2023-11-02
- Completion
- 2023-12-01
- First posted
- 2020-11-04
- Last updated
- 2025-01-15
- Results posted
- 2025-01-15
Locations
113 sites across 24 countries: United States, Armenia, Australia, Canada, Denmark, France, Georgia, Germany, Greece, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04615273. Inclusion in this directory is not an endorsement.