Evidence map›Paper›PMID 35263755›Full record

Trial reportHormone research in paediatrics2022

Switching to Weekly Lonapegsomatropin from Daily Somatropin in Children with Growth Hormone Deficiency: The fliGHt Trial.

Aristides K Maniatis, Ulhas Nadgir, Paul Saenger, Kent L Reifschneider, Jennifer Abuzzahab, Larry Deeb, Larry A Fox, Katie A Woods, Wenjie Song, Meng Mao and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Hormone research in paediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Long-acting growth hormone in 2022.Pediatric investigation · 2023
    Review
  12. Long acting growth hormone (LAGH), an update.Frontiers in pediatrics · 2023
    Review
  13. Review
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 3 countries.

Aristides K ManiatisRocky Mountain Pediatric Endocrinology, Centennial, Colorado, USA.
Ulhas NadgirCenter of Excellence in Diabetes and Endocrinology, Sacramento, California, USA.
Paul SaengerNYU Langone Health, New York University Langone, New York, New York, USA.
Kent L ReifschneiderHospital of The Kings Daughters, Norfolk, Virginia, USA.
Jennifer AbuzzahabChildren's Minnesota, Saint Paul, Minnesota, USA.
Larry DeebTMH Physician Partners Metabolic Health Center Pediatric Endocrinology, Tallahassee, Florida, USA.
Larry A FoxNemours Children's Health, Jacksonville, Florida, USA.
Katie A WoodsDoernbecher Children's Hospital at Oregon Health and Sciences University, Portland, Oregon, USA.
Wenjie SongAscendis Pharma, Incorporated, Palo Alto, California, USA.
Meng MaoAscendis Pharma, Incorporated, Palo Alto, California, USA.
Steven D ChesslerAscendis Pharma, Incorporated, Palo Alto, California, USA.
Allison S KomirenkoAscendis Pharma, Incorporated, Palo Alto, California, USA.
Aimee D ShuAscendis Pharma, Incorporated, Palo Alto, California, USA.
Samuel J CasellaChildren's Hospital at Dartmouth, Lebanon, New Hampshire, USA.
Paul S ThorntonCook Children's Medical Center, Fort Worth, Texas, USA.
Ascendis Pharma (Denmark) · DKChildren's Hospital at Dartmouth Hitchcock · USChildren's Hospital of The King's Daughters · USChildren’s Minnesota - St. Paul Hospital · USCook Children's Medical Center · USDiabetes Australia · AUDoernbecher Children's Hospital · USNemours Children's Health System · USNYU Langone Health · USTallahassee Memorial HealthCare · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe phase 3 fliGHt Trial evaluated the safety and tolerability of once-weekly lonapegsomatropin, a long-acting prodrug, in children with growth hormone deficiency (GHD) who switched from daily somatropin therapy to lonapegsomatropin.

methodsThis multicenter, open-label, 26-week phase 3 trial took place at 28 sites across 4 countries (Australia, Canada, New Zealand, and the USA). The trial enrolled 146 children with GHD, 143 of which were previously treated with daily somatropin. All subjects received once-weekly lonapegsomatropin 0.24 mg human growth hormone/kg/week. The primary outcome measure was safety and tolerability of lonapegsomatropin over 26 weeks. Secondary outcome measures assessed annualized height velocity (AHV), height standard deviation score (SDS), and IGF-1 SDS at 26 weeks.

resultsSubjects had a mean prior daily somatropin dose of 0.29 mg/kg/week. Treatment-emergent adverse events (AEs) reported were similar to the published AE profile of daily somatropin therapies. After switching to lonapegsomatropin, the least-squares mean (LSM) AHV was 8.7 cm/year (95% CI: 8.2, 9.2) at Week 26 and LSM height SDS changed from baseline to Week 26 of +0.25 (95% CI: 0.21, 0.29). Among switch subjects, the LSM for average IGF-1 SDS was sustained at Weeks 13 and 26, representing an approximate 0.7 increase from baseline (prior to switching from daily somatropin therapy). Patient-reported outcomes indicated a preference for weekly lonapegsomatropin among both children and their parents.

conclusionsLonapegsomatropin treatment outcomes were as expected across a range of ages and treatment experiences. Switching to lonapegsomatropin resulted in a similar AE profile to daily somatropin therapy.

Indexed as

Drug SubstitutionDwarfism, PituitaryGrowth HormoneHuman Growth HormoneBody HeightChildGrowth DisordersHumansInsulin-Like Growth Factor IGrowth HormoneHuman Growth HormoneInsulin-Like Growth Factor IlonapegsomatropinGrowth hormoneGrowth hormone deficiencyGrowth hormone replacement therapyLonapegsomatropinLong-acting growth hormoneTransCon human growth hormone

Identifiers

PMID35263755
PMCPMC9501775
OpenAlexW4221028503

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.