Evidence map›Paper›PMID 41420532›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2026

Efficacy and Safety of Once-Weekly Lonapegsomatropin in Adults With Growth Hormone Deficiency: foresiGHt Trial Results.

Beverly M K Biller, Aleksandra Gilis-Januszewska, Mirjana Doknic, Antonio Miguel Pico, Maria Fleseriu, Gerald Raverot, Andrea M Isidori, Yutaka Takahashi, Jose M Garcia, Julie M Silverstein and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04615273 (foresiGHt), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04615273 phase3completednot on this map

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

TypeinterventionalSponsorAscendis Pharma Endocrinology Division A/SRan2020 to 2023Enrolled264ConditionsGrowth Hormone Deficiency, Endocrine System Diseases, Hormone DeficiencyArmsLonapegsomatropin, Placebo, Somatropin
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Beverly M K BillerNeuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.ORCID 0000-0003-4359-4622
Aleksandra Gilis-JanuszewskaDepartment of Endocrinology, Jagiellonian University, Medical College, 30-688 Kraków, Poland.ORCID 0000-0002-9982-6499
Mirjana DoknicUniversity Clinical Center of Serbia, Medical Faculty University, 11000 Belgrade, Serbia.ORCID 0000-0003-2701-4800
Antonio Miguel PicoClinical Medicine, Alicante Institute for Health and Biomedical Research (ISABIAL), 03202 Elche, Alicante, Spain.ORCID 0000-0002-7549-7563
Maria FleseriuDepartment of Medicine and Neurological Surgery, Pituitary Center, Oregon Health and Science University, Portland, OR 97239, USA.ORCID 0000-0001-9284-6289
Gerald RaverotDepartment of Endocrinology, Hospices Civils de Lyon, 69 500 Lyon Cedex 03, France.ORCID 0000-0002-9517-338X
Andrea M IsidoriDepartment of Experimental Medicine, Sapienza University of Rome, 00185 Rome, Italy.ORCID 0000-0002-9037-5417
Yutaka TakahashiNara Medical University, Department of Diabetes and Endocrinology, Kashihara, Nara 634-8521, Japan.ORCID 0000-0002-1337-9246
Jose M GarciaDepartment of Medicine, University of Washington/GRECC, Puget Sound VA, Seattle, WA 98108, USA.ORCID 0000-0002-4245-1753
Julie M SilversteinDivision of Endocrinology, Metabolism & Lipid Research, Washington University School of Medicine, St Louis, MO 63110, USA.
Irina BancosDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, MN 55902, USA.ORCID 0000-0001-9332-2524
Hidenori FukuokaDivision of Diabetes and Endocrinology, Kobe University Hospital, Kobe 650-0017, Japan.ORCID 0000-0001-9255-653X
Eric HuangEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc., Palo Alto, CA 94304, USA.
Jennifer KangEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc., Palo Alto, CA 94304, USA.
Allison S KomirenkoEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc., Palo Alto, CA 94304, USA.ORCID 0000-0001-8844-2804
Laurie DomrzalskiEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc., Palo Alto, CA 94304, USA.
Aimee D ShuEndocrine and Rare Disease Medical Sciences, Ascendis Pharma, Inc., Palo Alto, CA 94304, USA.ORCID 0000-0003-1801-5289
Michael BeckertEndocrine and Rare Disease Medical Sciences, Ascendis Pharma A/S, 2900 Hellerup, Denmark.
Kevin C J YuenDepartment of Neuroendocrinology and Neurosurgery, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton University School of Medicine, Phoenix, AZ 85013, USA.ORCID 0000-0002-8169-2728

Funding

Ascendis Pharma Endocrinology Division A/S
6 · The paper itself

Abstract

contextAdult growth hormone (GH) deficiency (GHD) is characterized by metabolic abnormalities caused by insufficient GH production. Lonapegsomatropin, a prodrug administered once weekly, was designed to provide sustained release of unmodified somatropin to reduce the burden of daily somatropin injections.

objectiveThis work aimed to evaluate the efficacy and safety of lonapegsomatropin vs placebo as treatment for adults with GHD.

methodsThe foresiGHt trial was a multicenter, randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial (NCT04615273) conducted at 116 centers in North America, Europe, and Asia-Pacific. The trial randomly assigned and dosed 259 adults with GHD. Participants were randomly assigned 1:1:1 to receive once-weekly lonapegsomatropin, once-weekly placebo, or daily somatropin for 38 weeks. The primary efficacy end point was change from baseline in trunk percent fat at week 38. Secondary efficacy end points included change from baseline in trunk fat mass and total body lean mass.

resultsAt week 38, lonapegsomatropin significantly reduced trunk percent fat (-1.68% vs +0.37%; least squares [LS] mean difference -2.04%; P < .001), increased total body lean mass (+1.60 kg vs -0.11 kg; LS mean difference 1.70 kg; P < .0001), and reduced trunk fat mass (-0.48 kg vs +0.22 kg; LS mean difference -0.70 kg; P = .0053) vs placebo. The safety and tolerability profile of lonapegsomatropin was comparable to somatropin.

conclusionThe foresiGHt trial met its primary efficacy end point by demonstrating superiority of lonapegsomatropin vs placebo with similar safety and tolerability, supporting its potential as a once-weekly treatment option for adults with GHD.

Indexed as

Human Growth HormoneAdultDelayed-Action PreparationsDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultDelayed-Action PreparationsHuman Growth Hormonelonapegsomatropinadult growth hormone deficiencygrowth hormonegrowth hormone deficiencylong-acting growth hormone

Identifiers

PMID41420532
PMCPMC13183427

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Registered trials

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.