OUH02037

JRCT ID: jRCT2061220037

Registered date:22/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Treatment-naive acromegaly due to pituitary adenoma in a Japanese patient
• Date of first enrollment: 07/11/2022
• Target sample size: 8
• Study type: Interventional

Intervention(s)

In the 1st period, a single subcutaneous injection of GT-02037 2.0 milligram or Octreotide 50 microgram.
In the 2nd period, a single subcutaneous injection of a different investigational drug from the 1st period.

Outcome(s)

• Primary Outcome: Decreasing rate in blood GH level at the point of the largest decrease from the pre-administration value (Maximal reduction rate)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Japanese over 18 years old, at the time the informed consent was obtained
2. Patients with definite diagnosis of Acromegaly
3. Patients who give written consent with their free will prior to participation in this clinical trial

Exclude criteria

1. Patients who have undergone surgery to remove the pituitary gland tumor
2. Patients who have received radiation therapy for pituitary gland tumor
3. Patients receiving drug treatment with drugs that affect GH or the pituitary gland system (Somatostatin analogs, Dopamine agonists, GH antagonists, etc.), and the Investigator determines that these effects will remain at the time of study entry
4. Patients with a medical history of hypersensitivity to any of the components of the investigational drug in this study
5. Patients undergoing treatment for ongoing malignancies
6. Patients with serious systemic diseases (hepatic, renal, cardiovascular, endocrine, respiratory, etc.) or serious psychiatric diseases
7. Pregnant/possibly pregnant or lactating patients
8. HIV antigen/antibody, HBs antigen, or HCV antibody positive patients
9. Patients who have received any other investigational drug (including Post-marketing Clinical Trial drugs) within 12 weeks prior to the start of treatment with the investigational drug in this study
10. Patients with a history of alcohol or drug abuse within the past 12 months
11. Patients who are deemed unsuitable as subjects by the investigator

Related Information

• Primary Sponsor: Wada Jun
• Source(s) of Monetary Support: GlyTech, Inc.