NCT04615273|CompletedPhase 3ResultsFDA Drug

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

foresiGHt

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

Ascendis Pharma Endocrinology Division A/S ClinicalTrials.gov

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2 other identifiers

TCH-3062020-000929-42

Study Type

interventional

Target

264

Locations

24 countries

Sites

113

Timeline

RegisteredNov 2020

StartedDec 2020

CompletionDec 2023

Brief Summary

A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

264

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2020

Typical duration for phase_3

Geographic Reach

24 countries

113 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

October 29, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed

29 days until next milestone

Study Start

First participant enrolled

December 3, 2020

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2023

Completed

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

January 15, 2025

Completed

Last Updated

January 15, 2025

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

October 29, 2020

Results QC Date

December 20, 2024

Last Update Submit

December 20, 2024

Conditions

Growth Hormone Deficiency Endocrine System Diseases Hormone Deficiency

Keywords

Human Growth HormonehGHrhGHGHDAdult Growth Hormone DeficiencyLong-Acting Growth HormoneLonapegsomatropinProdrugGrowth FailureGrowth Hormone Replacement TherapySustained Release Growth HormoneGrowth Hormone DeficiencyTransCon hGH

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Trunk Percent Fat at Week 38
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Baseline, Week 38

Secondary Outcomes (3)

Change From Baseline in Total Body Lean Mass at Week 38
Baseline, Week 38
Change From Baseline in Trunk Fat Mass at Week 38
Baseline, Week 38
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
Up to 38 weeks

Study Arms (3)

Lonapegsomatropin

EXPERIMENTAL

Lonapegsomatropin administered once-weekly by subcutaneous injection.

Drug: Lonapegsomatropin

Placebo

PLACEBO COMPARATOR

Placebo for Lonapegsomatropin administered once-weekly by subcutaneous injection.

Other: Placebo

Somatropin

ACTIVE COMPARATOR

Somatropin administered once-daily by subcutaneous injection.

Drug: Somatropin

Interventions

LonapegsomatropinDRUG

Due to the different human growth hormone (hGH) dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.

Lonapegsomatropin

PlaceboOTHER

The placebo for lonapegsomatropin drug product contained the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution was administered by subcutaneous (SC) injection via syringe and needle. Due to the different hGH dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo received the same dose volume as if they were randomized to once-weekly lonapegsomatropin.

Placebo

SomatropinDRUG

Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.

Somatropin

Eligibility Criteria

Age23 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 23 and 80 years, inclusive, at screening.
Adult Growth Hormone Deficiency (AGHD) Diagnosis Criteria
For adult-onset AGHD: documented history of structural hypothalamic-pituitary disease, hypothalamic-pituitary surgery, cranial irradiation, 1-4 non-GH pituitary hormone deficiencies, a proven genetic cause of GHD, or traumatic brain injury (TBI).
Participants with childhood-onset GHD must have had GH axis re-assessed at final height.
In participants with TBI as a cause of GHD, GHD must be confirmed by GH -stimulation testing performed at least 12 months after the injury.
A. For all countries except Japan: participants must have satisfied at least one of the following criteria:
Insulin tolerance test: peak growth hormone (GH) \<=5 ng/mL
Glucagon stimulation test according to body mass index (BMI)
i. BMI \<=30 kg/m\^2: peak GH \<=3 ng/mL
ii. BMI \>30 kg/m\^2: peak GH \<=1 ng/mL
Three or four pituitary axis deficiencies (i.e., adrenal, thyroid, gonadal, and/or vasopressin; not including GH) with insulin-like growth factor-1 standard deviation score (IGF-1 SDS) \<= -2.0 at screening
Macimorelin test: peak GH \<=2.8 ng/mL
Growth hormone releasing hormone (GHRH) + arginine test according to BMI:
i. BMI \<25 kg/m\^2, peak GH \<11 ng/mL
ii. BMI \>=25-\<=30 kg/m\^2, peak GH \<8 ng/mL
+15 more criteria

You may not qualify if:

Known Prader-Willi Syndrome and/or other genetic diseases that may have an impact on an endpoint.
Diabetes mellitus at screening if any of the following criteria are met:
Poorly controlled diabetes, defined as HbA1c \>7.5% at screening.
Diabetes mellitus (defined as HbA1c \>=6.5% and/or fasting plasma glucose \>=126 mg/dL and/or plasma glucose \>=200 mg/dL two hours after oral glucose tolerance test) diagnosed \<26 weeks prior to screening
Change in diabetes regimen (includes dose adjustment) within \<90 days prior and throughout screening
Use of any diabetes drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors for a cumulative duration of greater than 4 weeks within 12 months prior to screening
Diabetes-related complications at screening (i.e., nephropathy as judged by the investigator, neuropathy requiring pharmacological treatment, retinopathy stage 2/moderate and above within 90 days prior to screening or during screening)
Resection of in situ carcinoma of the cervix uteri
Complete eradication of squamous cell or basal cell carcinoma of the skin
Participants with GHD attributed to treatment of intracranial malignant tumors or leukemia, provided that a recurrence-free survival period of at least 5 years prior to screening is documented in the participant's file (based on a Magnetic Resonance Imaging (MRI) result for intracranial malignant tumors)
Evidence of growth of pituitary adenoma or other benign intracranial tumor within the last 12 months before screening.
Participants with acromegaly without remission / with documented remission less than 24 months prior to screening.
Participants with Cushing's disease without remission / with documented remission less than 24 months prior to screening.
Participants with prior cranial irradiation or hypothalamic-pituitary surgery: the procedure was to take place less than 12 months prior to screening.
Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m\^2 determined based on Modification of Diet in Renal Disease (MDRD) equation.
+18 more criteria

Contact the study team to confirm eligibility.