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

• Conditions: Adult Growth Hormone Deficiency
• Interventions: Drug: Somapacitan

• Registration Number: NCT05230550
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-01-28
• Study Start: 2022-02-03
• Study First Posted: 2022-02-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with AGHD (only severe case)	Somapacitan	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 Outcome Measures

Name	Time	Method
Number of serious adverse reactions	From baseline (week 0) to end of study (up to 260 weeks)	Measured as number
Number of adverse events	From baseline (week 0) to end of study (up to 260 weeks)	Measured as number
Number of serious adverse events	From baseline (week 0) to end of study (up to 260 weeks)	Measured as number
Number of adverse reactions	From baseline (week 0) to end of study (up to 260 weeks)	Measured as number

Secondary Outcome Measures

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

Trial Locations

Locations (47)

Ikeda Hospital, Diabetes Medicine; 🇯🇵 Amagasaki-shi, Hyogo, Japan

University of Yamanashi Hospital; 🇯🇵 Chuo-shi, Yamanashi-ken, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka-ken, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus; 🇯🇵 Fukuoka, Japan

Kurume University Hospital; 🇯🇵 Fukuoka, Japan

Gifu University Hospital; 🇯🇵 Gifu, Japan

Tsugaru General Hospital; 🇯🇵 Goshogawara-shi, Aomori-ken, Japan

Gunma University Hospital, Dept. of Endocrinology and Diabetes; 🇯🇵 Gunma, Japan

Hamamatsu University Hospital; 🇯🇵 Hamamatsu-shi, Shizuoka, Japan

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