Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

NCTNCT05230550Other idNN8640-4638Other idU1111-1247-5417

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase not stated
Enrollment: 200 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Not stated
Countries: 1 country
Japan
Start: 3 Feb 2022
Primary completion: 31 Dec 2026 (estimated)
Completion: 31 Dec 2026 (estimated)
First posted: 9 Feb 2022
Last update posted: 13 Apr 2026
Conditions: Adult Growth Hormone Deficiency

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024202520262027

Ph –
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
NCT05230550
3 Feb 2022 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.

Interventions

SomapacitanDrug

Arms1

Other
Participants with AGHD (only severe case)
Participants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. The decision to treat a patient with Sogroya® has been made at the treating physician's discretion and independently from the decision to include the patient in this study.

Primary outcomes4

Outcomes the sponsor listed as primary.

Number of adverse events
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as number
Number of serious adverse events
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as number
Number of serious adverse reactions
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as number
Number of adverse reactions
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as number

Secondary outcomes(13)

Change in body fat mass
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as kilogram (kg)
Change in body fat percentage
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as percent (%)
Change in lean body mass
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as kg
Change in cross-sectional total adipose tissue compartments (TAT)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as square centimeter (cm\^2)
Change in subcutaneous adipose tissue compartments (SAT)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as cm\^2
Change in visceral adipose tissue compartments (VAT)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as cm\^2
Change in Total cholesterol (T-Cho)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as milligrams per deciliter (mg/dL)
Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as mg/dL
Change in High Density Lipoprotein-Cholesterol (HDL-Cho)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as mg/dL
Change in triglyceride
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as mg/dL
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as standard deviation score
Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as score range (0 = unfavorable to 6 = favorable)
Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score
Time frame · From baseline (week 0) to end of study (up to 260 weeks)
Registry description
Measured as score range (1 to 5; lower score indicates a better health state)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: Not stated
Healthy volunteers: Not stated

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) 2. The decision to initiate treatment with commercially available Sogroya® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study. 3. Male or female, no age limitation 4. Diagnosis of AGHD (only severe case) 5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3. Patients with hypersensitivity to the active substance or to any of the excipients 4. Patients with malignant tumor 5. Female patients who are either pregnant or likely to be pregnant

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