A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia

This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.

Start Date26 Jul 2024

Sponsor / Collaborator

Ascendis Pharma Growth Disorders A/S

CTIS2023-508341-40-00

/ Not yet recruitingPhase 2

COACH: A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children with Achondroplasia - ASND0042

Start Date26 Jul 2024

Sponsor / Collaborator

Ascendis Pharma Growth Disorders A/S

EUCTR2021-004313-39-DE

/ Not yet recruitingPhase 3

A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults with Growth Hormone Deficiency

Start Date31 May 2023

Sponsor / Collaborator

Ascendis Pharma Endocrinology Division A/S

100 Clinical Results associated with Lonapegsomatropin-tcgd

100 Translational Medicine associated with Lonapegsomatropin-tcgd

100 Patents (Medical) associated with Lonapegsomatropin-tcgd

Literatures (Medical) associated with Lonapegsomatropin-tcgd

26 Mar 2025·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Clinical outcomes of switching to lonapegsomatropin from somatropin for treatment of pediatric growth hormone deficiency

Article

Author: Coyne, Emma ; Muthuvel, Gajanthan ; Gutmark-Little, Iris

Abstract:

Objectives:

This study aimed to assess differences in insulin-like growth factor 1 (IGF-1) levels following the transition from somatropin to lonapegsomatropin in patients with pediatric growth hormone deficiency (GHD). Secondary objectives included the evaluation of dose titrations based on IGF-1 levels, changes in annualized height velocity (AHV) and body mass index (BMI), and assessing reported adverse effects associated with lonapegsomatropin therapy.

Methods:

A single-center, retrospective review was conducted including patients diagnosed with pediatric GHD initially treated with somatropin who transitioned to lonapegsomatropin between January 1, 2022, and December 31, 2023.

Results:

Fourteen patients (median age: 9 years) were included. The median somatropin dose was 0.18 mg/kg/week (range, 0.09 to 0.29) at the time of transition and patients were initiated on a median lonapegsomatropin dose of 0.23 mg/kg/week (range, 0.15 to 0.26). This resulted in an IGF-1 increase of 2.3 SDS post-switch. Dose adjustments were made based on IGF-1 levels. Five patients required immediate dose reductions; four of these required further adjustments due to persistent elevation. There were no serious adverse effects reported.

Conclusions:

Lonapegsomatropin may be a favorable option to reduce injection burden for those with pediatric GHD, though the manufacturer’s recommended starting dose of 0.24 mg/kg/week may require individualization. Careful monitoring and dose adjustment based on IGF-1 levels are necessary to maintain safety and efficacy.

01 Mar 2025·Sports health

Can Human Growth Hormone Accelerate Tendon and Ligament Injury Recovery?

Article

Author: Sun, Hongli ; Baumgarten, Keith M. ; Sandhurst, Eric S.

Background::

Studies involving human fibroblasts and use of human growth hormone (HGH) administration for injury recovery are limited. It is plausible that if the administration of HGH to human cells increased cellular proliferation and differentiation, then HGH might be able to assist in accelerating recovery from injury.

Hypothesis::

HGH will increase proliferation and differentiation of human tendon and ligament fibroblasts in vitro based on both a single-dose and a sustained-dose model of HGH administration.

Study Design::

Basic science cellular study.

Methods::

Human tendon and ligament tissue were harvested from 24 patients. Tissue samples were digested with type I collagenase to isolate the target cell types. HGH was administered directly to isolated cells at doses ranging from 100 pg/mL to 10 µg/mL, either in a single-dose or a sustained-dose model. Proliferation was analyzed at days 4 and 7. Differentiation of ligament and tendon fibroblasts was assessed at day 14.

Results::

Administration of a single-dose of HGH to both cell types demonstrated similar or inferior cellular proliferation compared with controls after 7 days. For the sustained-dosing model of ligament fibroblasts, only the 100 ng/mL concentration demonstrated at least statistically similar or improved proliferation compared with controls. When examining the 100 ng/mL HGH concentration with larger sample sizes, cellular proliferation was not improved over controls for any cell type for the single- or sustained-dosing models. Proliferation for tendon fibroblasts was either similar or inferior to the control group at all concentrations of HGH. There was no clear dose-response relationship demonstrating enhanced collagen production with administration of HGH to suggest it enhances injury recovery.

Conclusion::

HGH administered to human tendon and ligament fibroblasts does not appear to positively affect cellular proliferation and differentiation.

Clinical Relevance::

This study does not support the use of HGH for accelerating recovery from injury.

01 Jan 2025·Clinical Pediatric Endocrinology

Current understanding and perspectives on growth and long-acting GH therapy in Japan

Review

Author: Ariyasu, Daisuke ; Amano, Naoko ; Mitani-Konno, Marie ; Ikegawa, Kento ; Hasegawa, Yukihiro

From the perspective of clinical pediatric endocrinology, progress in molecular biology over the past few decades has improved our understanding of growth physiology. This progress was particularly conspicuous in the early era of Sanger-based sequencing and has continued into the current era of next-generation sequencing. The first half of this review summarizes the current understanding about growth. The latter half discusses the development of long-acting GH (LAGH), an important, recent topic in pediatric endocrinology, with a focus on the Japanese market. LAGH is administered weekly over several years in some developed countries as treatment for GH deficiency (GHD). In Japan, somatrogon and somapacitan are available, and lonapegsomatropin has completed a clinical trial. As per recent meta-analyses, these three products were not inferior to conventional, daily GH therapy for short-term growth in pediatric GHD. Although LAGH is promising, some concerns remain. Well-designed clinical research is needed to expand the indications for LAGH to other conditions, such as idiopathic short stature. Finally, future research on orally administered agents may open new avenues for the treatment of short stature.

News (Medical) associated with Lonapegsomatropin-tcgd

21 Mar 2025

·www.fiercepharma.com

Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO

Visen Pharmaceuticals is designed to develop and commercialize Ascendis’ endocrinology therapies in greater China. Endocrine-disease-focused Visen Pharmaceuticals is making its public market debut in Hong Kong, filing papers for an $86.5 million IPO.The China-based biotech was formed in 2018 by Ascendis Pharma and an investor syndicate led by Vivo Capital. The biotech is designed to develop and commercialize Ascendis’ endocrinology therapies in greater China.Now, Visen is going public, with expected gross proceeds of $100 million, according to March 20 regulatory filings (PDF). The company has previously raised about $190 million, closing a $150 million series B financing in early 2021. That fundraise included OrbiMed, Logos Capital, Ascendis Pharma, Vivo Capital and Sofinnova Investments, among others.The company hosts three programs in its pipeline: Yorvipath (palopegteriparatide) for adults with chronic hypoparathyroidism; Skytrofa (lonapegsomatropin) for pediatric growth hormone deficiency; and navepegritide, an investigational prodrug of C-type natriuretic peptide for achondroplasia.

IPO

12 Jan 2025

·www.globenewswire.com

Ascendis Pharma Provides Business and Strategic Roadmap Update at 43rd Annual J.P. Morgan Healthcare Conference

- Ascendis positioned to drive rapid revenue growth COPENHAGEN, Denmark, Jan. 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today provided a business and strategic roadmap update, including planned 2025 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present this update tomorrow, January 13, during the 43rd Annual J.P. Morgan Healthcare Conference. “Ascendis is well-positioned for rapid revenue growth with the launch of our first two Endocrinology Rare Disease medicines, SKYTROFA and YORVIPATH, and, following our pre-NDA meeting, planned filings for our third, TransCon CNP for achondroplasia,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Our expanding TransCon technology platform and partnerships demonstrate that our business model built on fast, successful drug development can create substantial stakeholder value.” Selected Key Updates and Milestones TransCon™ hGH (lonapegsomatropin, marketed as SKYTROFA®) SKYTROFA full-year 2024 revenue, with a single indication in pediatric GHD, expected to be ~€202 million excluding sales deductions related to prior years (based on unaudited preliminary estimate of full-year 2024 SKYTROFA revenue of ~€197 million plus ~€5 million of sales deductions related to prior years).U.S. SKYTROFA volume (mg) increased 84% in 2024 year-over-year resulting in an estimated 6.5% market share of the total U.S. growth hormone market for 2024 (based on third party prescription data).Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025 for FDA review of supplemental BLA for the treatment of adults with growth hormone deficiency; pending approval, U.S. commercial launch planned in the fourth quarter of 2025.During the third quarter of 2025, plan to submit an Investigational New Drug (IND) application or similar for a basket trial evaluating TransCon hGH in additional indications. TransCon PTH (palopegteriparatide, marketed as YORVIPATH®) YORVIPATH full-year 2024 unaudited preliminary revenue estimate of ~€29 million.YORVIPATH commercially available for prescription in Germany and Austria since January 2024. Outside Germany and Austria, providing product through early access routes, such as ‘named patient,’ until commercial reimbursement established. ~700 patients on treatment in our Europe Direct and International Markets at the end of 2024.YORVIPATH commercially available for prescription since late December 2024 in the U.S. As of January 9, 2025, 324 patients enrolled into the Ascendis Signature Access Program or direct with specialty pharmacy, with over half of prescriptions for patients new to YORVIPATH.Expect commercial launch in at least five additional Europe Direct countries in 2025. TransCon CNP (navepegritide) Following pre-NDA meeting with FDA, plan to submit New Drug Application (NDA) for the treatment of children with achondroplasia during the first quarter of 2025, and submit Marketing Authorisation Application to the European Medicines Agency during the third quarter of 2025.Presented new data demonstrating significant improvements in leg bowing, a common complication in achondroplasia, observed with TransCon CNP compared to worsening observed with placebo in pivotal ApproaCH Trial.Topline Week 26 results from Phase 2 COACH Trial (TransCon CNP in combination with TransCon hGH) expected in the second quarter of 2025.During the fourth quarter of 2025, plan to submit an IND or similar for the treatment of hypochondroplasia. Expanding the TransCon Platform & Pipeline New TransCon protein degrader platform designed to enable efficient clearance of hormones, cytokines, and other targets. First planned TransCon protein degrader product candidate designed to normalize excess FGF-23 hormone levels for patients with X-linked hypophosphatemia. Financial Update Unaudited preliminary estimate of total full-year 2024 product revenue of ~€226 million: SKYTROFA full-year 2024 revenue expected to be ~€202 million excluding sales deductions related to prior years (based on unaudited preliminary estimate of full-year 2024 SKYTROFA revenue of ~€197 million plus ~€5 million of sales deductions related to prior years).YORVIPATH full-year 2024 unaudited preliminary revenue estimate of ~€29 million. Unaudited preliminary estimate of total full-year total 2024 revenue of ~€364 million Includes $100 million Novo Nordisk milestone payment as non-product revenue. December 31, 2024 pro forma cash balance of ~€655 million (based on unaudited preliminary estimate of December 31, 2024 cash balance of €560 million plus expected payment from Novo Nordisk of $100 million). Presentation at J.P. Morgan Healthcare Conference on Monday, January 13A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. The presentation will begin at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time. A webcast replay will be available for 30 days. The Company’s slides from the J.P. Morgan presentation will be available on the same Investor Relations website at https://investors.ascendispharma.com. About Ascendis Pharma A/SAscendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ potential for rapid revenue growth, (ii) planned regulatory submissions for TransCon CNP and TransCon hGH, (iii) the ability of Ascendis’ business model to create substantial stakeholder value, (iv) expected full-year 2024 SKYTROFA, YORVIPATH and total revenues, (v) the PDUFA date of the supplemental BLA for SKYTROFA for the treatment of adults with growth hormone deficiency and Ascendis’ plans for a U.S. commercial launch, if approved, (vi) Ascendis’ expectations regarding the commercial launch of YORVIPATH in additional Europe Direct Countries, (vii) the timing of topline results from the Phase 2 COACH Trial of TransCon CNP, (viii) Ascendis’ expectations regarding its TransCon protein degrader platform and first TransCon degrader product candidate, (ix) the expected payment from Novo Nordisk, (x) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (xi) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ prospectus supplement filed on September 20, 2024 and Ascendis’ current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on February 7, 2024. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, SKYTROFA®, and YORVIPATH® are trademarks owned by the Ascendis Pharma group. © January 2025 Ascendis Pharma A/S. Investor Contacts:Media Contact:Scott SmithMelinda BakerAscendis PharmaAscendis Pharmair@ascendispharma.com +1 (650) 709-8875 media@ascendispharma.comPatti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com

Phase 2NDAClinical Result

16 Dec 2024

·www.globenewswire.com

New InsiGHTS Trial of TransCon™ hGH (Lonapegsomatropin) in Turner Syndrome Achieved Primary Objective at Week 26

- Results for all three TransCon hGH starting dose cohorts, in first clinical trial of an indication outside of growth hormone deficiency, showed a safety and tolerability profile comparable to daily somatropin - Annualized height velocity was similar at Week 26 in once-weekly TransCon hGH-treated and daily somatropin-treated children COPENHAGEN, Denmark, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive Week 26 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. to investigate the safety, tolerability, and efficacy of once-weekly TransCon hGH (lonapegsomatropin; approved for pediatric growth hormone deficiency) compared to daily somatropin in prepubertal children with Turner syndrome. New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old into one of four treatment groups 1:1:1:1 – one of three starting doses of TransCon hGH (0.24, 0.30, or 0.36 mg/kg/week) or an active comparator of daily somatropin with a starting dose of 0.35 mg/kg/week. Doses were individualized based on IGF-1. On the primary endpoint of annualized height velocity and secondary endpoint of change from baseline in height SDS, children treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26, independent of starting dose.In the trial, TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily somatropin. “Week 26 topline data from the New InsiGHTS Trial showed that once-weekly TransCon hGH provided comparable safety and endocrine benefits to those seen with the established use of daily somatropin in Turner syndrome,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “These positive results lay the foundation for our planned basket trial in 2025 to support label expansion.” Ascendis expects Week 52 results for lonapegsomatropin-treated children compared to daily somatropin-treated children in 2025. About Turner SyndromeTurner syndrome is the most common congenital sex chromosomal condition in females, with an estimated prevalence of 1 out of every 2,000 to 2,500 live female births. Short stature, associated with short stature homeobox-containing gene (SHOX) haploinsufficiency, is the most common clinical feature of Turner syndrome. Clinical manifestations of Turner syndrome affect multiple organ systems and are associated with significant and potentially life-threatening complications including cardiovascular disease, ovarian dysfunction, endocrine disease, renal malformation, liver disease, sensorineural hearing loss, and varied neuropsychological manifestations. About Ascendis Pharma A/SAscendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the timing of Week 52 results for lonapegsomatropin-treated patients compared to daily somatropin-treated patients, (ii) Ascendis’ plans for a basket trial in 2025 and SKYTROFA’s potential label expansion, (iii) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company, and (iv) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ prospectus supplement filed on September 20, 2024 and Ascendis’ current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 20-F filed with the SEC on February 7, 2024. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © December 2024 Ascendis Pharma A/S. Investor Contacts:Media Contact:Scott SmithMelinda BakerAscendis PharmaAscendis Pharmair@ascendispharma.com+1 (650) 709-8875 media@ascendispharma.comPatti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com

Clinical ResultDrug ApprovalPhase 2

100 Deals associated with Lonapegsomatropin-tcgd

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lonapegsomatropin-tcgd	-	DB16220

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Growth hormone deficiency	United States	Ascendis Pharma Endocrinology Division A/S	25 Aug 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Endocrine System Diseases	Phase 3	China	Ascendis Pharma A/S	30 Dec 2019
Endocrine System Diseases	Phase 3	China	VISEN Pharmaceuticals (Shanghai) Co., Ltd.	30 Dec 2019
Pituitary Diseases	Phase 3	China	Ascendis Pharma A/S	30 Dec 2019
Pituitary Diseases	Phase 3	China	VISEN Pharmaceuticals (Shanghai) Co., Ltd.	30 Dec 2019
Achondroplasia	Phase 2	Denmark	Ascendis Pharma Growth Disorders A/S	26 Jul 2024
Achondroplasia	Phase 2	Ireland	Ascendis Pharma Growth Disorders A/S	26 Jul 2024
Achondroplasia	Phase 2	United Kingdom	Ascendis Pharma Growth Disorders A/S	26 Jul 2024
Turner Syndrome	Phase 2	United States	Ascendis Pharma A/S	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04615273 (foresiGHt, CTgov)	Phase 3	Growth hormone deficiency	264	Lonapegsomatropin (Lonapegsomatropin)	udidbborxq(adncoulidt) = mpdmxaudhg lqbwdajpkn (ncgupikqbn, puxhesmspf - oiiugfsvzl) View more	-	25 Mar 2025
				Placebo (Placebo)	udidbborxq(adncoulidt) = wyolebcxwh lqbwdajpkn (ncgupikqbn, hhhdudzvem - wxtnjpxbal) View more
NCT03344458 (enliGHten, CTgov)	Phase 3	Growth hormone deficiency	298	Lonapegsomatropin	zabgueykko = qxxrpusvyj crmbpdiwif (uyqkfdmmvf, uilejauxqe - mzgxqqknum) View more	-	08 May 2024
NCT04615273 (foresiGHt, Biospace) Manual	Phase 3	Growth hormone deficiency	259	TransCon hGH	rbgcdfuils(bmxtbxfvxi) = lfyerwxbho omnbzpjeus (rtnxfxsien ) View more	Positive	19 Dec 2023
				Placebo	rbgcdfuils(bmxtbxfvxi) = htpgmcsojc omnbzpjeus (rtnxfxsien ) View more
NCT03344458 (enliGHten, GlobeNewswire) Manual	Not Applicable	Growth hormone deficiency	81	TransCon hGH	jlnqmrgevy(hcwzlonglj) = The most commonly reported adverse events over the course of the trial were categorized as infections, injury, and respiratory/thoracic/medical disorders. The majority of adverse events were mild in severity and unrelated to treatment. No adverse events led to discontinuation of the study treatment. pisfdbsogh (wsrwhnbtpb )	Positive	23 Sep 2023
				TransCon hGH (at the beginning of the open-label extension trial)
NCT04326374 (PRNewswire) Manual	Phase 3	Growth hormone deficiency	150	human growth hormone (Longpei growth promoting hormone group)	nxeaekskzc(tygngosaef) = qbbjgxqhih oublujtjdz (hryxkqqpie )	Positive	17 Nov 2022
				human growth hormone (growth hormone daily preparation group)	nxeaekskzc(tygngosaef) = bxzldmfgjf oublujtjdz (hryxkqqpie )
enliGHten Trial (ENDO2022)	Phase 3	Growth hormone deficiency	298	Lonapegsomatropin via vial/syringe	vpjunlnydh(lizsfwpdxa) = With continued lonapegsomatropin treatment, the AE profile remained consistent with what was observed in the parent trials, with no new safety signals yljevlwxvr (fderraztsz )	Positive	01 Nov 2022
NCT04326374 (PRNewswire) Manual	Phase 3	Growth hormone deficiency	150	lonapegsomatropin	gfqcyzxmxp(zyddzlephb): P-Value = 0.0010	Superior	23 May 2022
				daily growth hormone
NCT03305016 (CTgov)	Phase 3	Growth hormone deficiency	146	Lonapegsomatropin	mrlzdpfeol = pycdeoroej iejaviqgjf (coiwgkgisq, pguvzlfvwq - hwbytcggtm) View more	-	04 Jan 2022
heiGHt Trial (ENDO2020)	Phase 3	Growth hormone deficiency Maintenance	159	TransCon hGH	sshnrvgaie(mkmtnrhmxn) = nnyrbkofch itzapkzfhz (exdhagtdmc ) View more	Positive	08 May 2020
				Genotropin	sshnrvgaie(mkmtnrhmxn) = exvtnjaubh itzapkzfhz (exdhagtdmc )
NCT01947907 (Pubmed \| J Clin Endocrinol Metab) Manual	Phase 2	Growth hormone deficiency	53	TransCon GH	iijodbrluf(gojadsgoor) = zaifnksttc otlyhpiemv (hnsumplrss )	Positive	01 May 2017
				Genotropin	iijodbrluf(gojadsgoor) = ayhqlsgilz otlyhpiemv (hnsumplrss )

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