CompletedPhase 3

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

United States220 participantsStarted 2021-12-16

Plain-language summary

This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants were adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt; NCT04615273).

Who can participate

Age range23 Years – 81 Years

SexALL

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Exclusion criteria

✕. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
✕. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation

Timeframe: Up to 52 Weeks

Trial details

NCT IDNCT05171855

SponsorAscendis Pharma Endocrinology Division A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-23

Results submitted2025-12-18

View on ClinicalTrials.gov More Adult Growth Hormone Deficiency trials