The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

The Effect of Subcutaneous Infusions of 3 Doses of a Novel Somatostatin Analogue, DG3173, on Growth Hormone Levels in Untreated Acromegalics

This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: Drug: saline; Drug: DG3173; Drug: octreotide

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception
• Diagnosis of acromegaly of pituitary origin
• Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening
• Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening
• Have given written informed consent
• Ability to comply with the requirements of the protocol for the study

Exclusion Criteria:

• Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant
• Treatment with dopamine agonists in the 3 months prior to screening
• Uncontrolled hypertension
• Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin [HbA1c] ≥7.5%) and patients requiring insulin treatment
• Gallstones or gravel that could cause biliary obstruction
• Hyperprolactinaemia
• Participation in a clinical study within 60 days prior to screening
• Receipt of blood, blood products or plasma derivatives 60 days prior to screening
• Body mass index (BMI) below 22 or above 37 kg/m2
• Pregnancy, lactation or use of any hormonal based contraceptives
• Concomitant intake of corticosteroids or levodopa
• A history of active alcohol abuse or drug addiction
• Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2
• Evidence or suspicion of tumour expansion
• Clinically significant abnormality in screening ECG in the opinion of the Investigator
• Any clinically significant abnormal in screening laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator
• Any disease which in the Investigator's opinion would exclude the patient from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Saline, then DG3173, then octreotide; Interventions: saline, DG3173 and octreotide. Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.

Drug: saline; Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.; Drug: DG3173; Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.; Drug: octreotide; Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment.	23 hours following each treatment

Collaborators and Investigators

• Sponsor: Aspireo Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (ESTIMATE): August 15, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: DG3173-II-02