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

NCT02217800 | Completed Phase 2 Results

• 1 other identifier: DG3173-II-02
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Saline, then DG3173, then octreotide

OTHER

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; Drug: DG3173; Drug: octreotide

Interventions

saline DRUG

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.

Saline, then DG3173, then octreotide

DG3173 DRUG

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.

Saline, then DG3173, then octreotide

octreotide DRUG

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.

Saline, then DG3173, then octreotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aspireo Pharmaceuticals Limited: lead

MeSH Terms

Conditions

Acromegaly

Interventions

Sodium Chloride; PTR 3173; Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Fredric Cohen, MD
• Organization: Strongbridge Biopharma

f.cohen@strongbridgebio.com

610-254-9200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 15, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2016
• Last Updated: February 15, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-01