Trial · NCT04615273

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

NCT04615273, Phase 3, Completed, Ascendis Pharma Endocrinology Division A/S; results first posted 2025-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency. Trials, record NCT04615273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04615273

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
NCT number: NCT04615273
Status: Completed
Phases: Phase 3
Enrollment: 264 participants, actual
Lead sponsor: Ascendis Pharma Endocrinology Division A/S
Conditions: Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
Interventions: Lonapegsomatropin, Placebo, Somatropin
First posted: 2020-11-04
Last updated: 2026-07-07
Other registries' IDs: eudract:2020-000929-42
Results first posted: 2025-01-15

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Trunk Percent Fat at Week 38	Baseline, Week 38	Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Secondary	Change From Baseline in Total Body Lean Mass at Week 38	Baseline, Week 38	Total body lean mass was assessed by dual-energy X-ray absorptiometry.
Secondary	Change From Baseline in Trunk Fat Mass at Week 38	Baseline, Week 38	Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Up to 38 weeks	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE is any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Trunk Percent Fat at Week 38	Baseline, Week 38	Analysis was performed on Intent-To-Treat population that consisted of all randomized participants who received any amount of the trial drug and were analyzed by the treatment arm as randomized. Here, Overall number of participants analyzed = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for lonapegsomatropin and placebo groups, and not for somatropin group.	percent fat	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Body Lean Mass at Week 38	Baseline, Week 38	Analysis was performed on Intent-to-Treat population. Here, Overall number of participants analyzed = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for lonapegsomatropin and placebo groups, and not for somatropin group.	kilograms	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Trunk Fat Mass at Week 38	Baseline, Week 38	Analysis was performed on Intent-to-Treat population. Here, Overall number of participants analyzed = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for lonapegsomatropin and placebo groups, and not for somatropin group.	kilograms	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Up to 38 weeks	Analysis was performed on safety population that included all randomized participants who received any amount of trial drug and was analyzed by the actual treatment received.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Trunk Percent Fat at Week 38	Lonapegsomatropin		-1.68	95% Confidence Interval -2.44 to -0.91	percent fat
Change From Baseline in Trunk Percent Fat at Week 38	Placebo		0.37	95% Confidence Interval -0.30 to 1.03	percent fat
Change From Baseline in Total Body Lean Mass at Week 38	Lonapegsomatropin		1.60	95% Confidence Interval 1.00 to 2.19	kilograms
Change From Baseline in Total Body Lean Mass at Week 38	Placebo		-0.11	95% Confidence Interval -0.72 to 0.51	kilograms
Change From Baseline in Trunk Fat Mass at Week 38	Lonapegsomatropin		-0.48	95% Confidence Interval -0.89 to -0.07	kilograms
Change From Baseline in Trunk Fat Mass at Week 38	Placebo		0.22	95% Confidence Interval -0.15 to 0.60	kilograms
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Lonapegsomatropin	TEAEs	64		Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Placebo	TEAEs	55		Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Somatropin	TEAEs	63		Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Lonapegsomatropin	Serious TEAEs	4		Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lonapegsomatropin	90
Overall Study	STARTED	Placebo	87
Overall Study	STARTED	Somatropin	87
Overall Study	Treated	Lonapegsomatropin	89
Overall Study	Treated	Placebo	84
Overall Study	Treated	Somatropin	86
Overall Study	COMPLETED	Lonapegsomatropin	85
Overall Study	COMPLETED	Placebo	81
Overall Study	COMPLETED	Somatropin	82
Overall Study	NOT COMPLETED	Lonapegsomatropin	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events51

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	COVID-19	Infections and infestations	Lonapegsomatropin	7	89	7
other	COVID-19	Infections and infestations	Placebo	11	84	11
other	COVID-19	Infections and infestations	Somatropin	6	86	7
other	Arthralgia	Musculoskeletal and connective tissue disorders	Lonapegsomatropin	8	89	8
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	8	84	8
other	Arthralgia	Musculoskeletal and connective tissue disorders	Somatropin	7	86	9
other	Nasopharyngitis	Infections and infestations	Lonapegsomatropin	5	89	6
other	Nasopharyngitis	Infections and infestations	Placebo	11	84	16
other	Nasopharyngitis	Infections and infestations	Somatropin	6	86	7
other	Headache	Nervous system disorders	Lonapegsomatropin	7	89	13

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lonapegsomatropin	0	89
Total, all-cause mortality	Placebo	0	84
Total, all-cause mortality	Somatropin	0	86
Total, other adverse events	Lonapegsomatropin	29	89
Total, other adverse events	Placebo	47	84
Total, other adverse events	Somatropin	28	86
Total, serious adverse events	Lonapegsomatropin	4	89
Total, serious adverse events	Placebo	1	84
Total, serious adverse events	Somatropin	6	86

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04615273

GET https://conductscience.org/api/trials/v1/NCT04615273/events?page=2

API reference For AI assistants