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Lonapegsomatropin for Growth Hormone Deficiency

Ascendis Pharma Investigational Site, Kobe, Japan
Growth Hormone Deficiency+2 More ConditionsLonapegsomatropin - Drug
Eligibility
23 - 81
All Sexes
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Study Summary

This trial is designed to evaluate the long-term safety and efficacy of a growth hormone deficiency treatment administered once-weekly. The study participants are adults (males and females) who have completed the treatment period in a previous study.

Eligible Conditions
  • Adult Onset Growth Hormone Deficiency
  • Endocrine Disorders
  • Hormone Deficiency

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
AEVI-007 (CERC-007, AVTX-007)
1
Growth Hormone
1
Lonapegsomatropin at 0.24 mg hGH/kg/week

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Week 52

Week 52
Incidence of Treatment-Emergent Adverse Events
Week 52
Change from Baseline in Total Body Lean Mass
Change from Baseline in Trunk Fat Mass
Change from Baseline in Trunk Percent Fat
Evaluate serum IGF-1 and IGF-1 SDS
Evaluate serum hGH, lonapegsomatropin, and mPEG levels

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
AEVI-007 (CERC-007, AVTX-007)
2
Growth Hormone
2
Lonapegsomatropin at 0.24 mg hGH/kg/week

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Lonapegsomatropin
1 of 1

Experimental Treatment

240 Total Participants · 1 Treatment Group

Primary Treatment: Lonapegsomatropin · No Placebo Group · Phase 3

Lonapegsomatropin
Drug
Experimental Group · 1 Intervention: Lonapegsomatropin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52

Who is running the clinical trial?

Ascendis Pharma Endocrinology Division A/SLead Sponsor
6 Previous Clinical Trials
2,020 Total Patients Enrolled

Eligibility Criteria

Age 23 - 81 · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the efficacy of Lonapegsomatropin in previous clinical trials?

"At this moment, there are 2 concurrent clinical trials testing Lonapegsomatropin. These studies have reached Phase 3 and are being conducted in 56 different locations." - Anonymous Online Contributor

Unverified Answer

Would this experiment be interested in participants who are over 30 years old?

"According to the inclusion criteria found on this clinical trial's website, 23 studies are for people under 18 years old and 28 are for patients 65 and older." - Anonymous Online Contributor

Unverified Answer

What is the FDA's assessment of Lonapegsomatropin?

"Given that this is a Phase 3 trial, our team has determined that the Lonapegsomatropin drug intervention is safe (scoring a 3 on our 1-3 scale). There is efficacy data as well as multiple rounds of safety data supporting this assumption." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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