Lonapegsomatropin for Growth Hormone Deficiency

Recruiting at 76 trial locations

Overseen By Aimee D Shu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ascendis Pharma Endocrinology Division A/S

Must be taking: Growth hormone

Must not be taking: Diabetes drugs

Disqualifiers: Diabetes, Malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

233 Participants Needed

Trial Summary

What is the purpose of this trial?

This is 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 are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

Eligibility Criteria

Adults with confirmed growth hormone deficiency who completed the TCH-306 study can join. They must have signed consent, finished previous trial treatments, and had certain medical checks without serious issues. People with uncontrolled diabetes, active cancer (with some exceptions), or unwillingness to use contraception cannot participate.

Inclusion Criteria

Signing of the trial specific informed consent

My last eye exam showed no signs of high brain pressure or serious diabetes-related eye problems.

Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 DXA scan

Exclusion Criteria

I am taking diabetes medication that is not metformin or DPP-4 inhibitors.

My diabetes is not well-controlled, with an HbA1C over 7.5%.

You have had a bad reaction to the study drug somatropin or any of its ingredients in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lonapegsomatropin once-weekly by subcutaneous injection

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Long-term evaluation of safety and efficacy of Lonapegsomatropin

Long-term

Treatment Details

Interventions

• Lonapegsomatropin

Trial Overview The trial is testing Lonapegsomatropin's long-term effects when given once a week to adults with growth hormone deficiency. It's an open-label phase 3 study, meaning both researchers and participants know what treatment is being used.

Participant Groups

Group I: Lonapegsomatropin Experimental Treatment 1 Intervention

Lonapegsomatropin administered once-weekly by subcutaneous injection

Who Is Running the Clinical Trial?

Ascendis Pharma Endocrinology Division A/S

Lead Sponsor

Trials

7

Recruited

2,300+