Single ascending dose study for Two Glucagon compounds
Research type
Research Study
Full title
Protocol I7U-MC-GAHA A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects
IRAS ID
165203
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2014-002347-18
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
Glucagon is a hormone produced in the pancreas that helps in the breakdown of stored glycogen (glucose stored in the body) into glucose. This action of glucagon restores blood glucose levels when they fall below normal (ie, hypoglycaemia). Severe hypoglycaemia is a potentially life-threatening complication that is usually due to excessive, unopposed action of administered insulin in patients with type 1 or 2 diabetes.
Administration of glucagon is the standard of care for the treatment of severe hypoglycaemia. Current commercial glucagon products are provided as a powder that must be reconstituted with a diluent at time of administration, which is burdensome and time consuming, especially in an emergency situation when someone is in need of immediate intervention. A new glucagon therapy is needed that will allow caregivers to quickly and confidently treat severe hypoglycaemia events without requiring prior reconstitution.
The goal is to develop a glucagon peptide analogue (similar compound) with improved solubility and physical and chemical stabilities that can be administered via a simple single-use device for the treatment of severe hypoglycaemia (as an emergency administration). The IMPs (investigational medicinal products) used in this study, are chemically synthesised linear peptide analogues of glucagon.
This is the first in human, single ascending dose study to characterise the safety, tolerability and PK/PD (concentration in blood after administration / what does the drug do to the body ) characteristics of the glucagon analogues. The study is intended to establish dose exposure response relationships which will identify doses that produce PD responses that might be expected from rGlucagon at the approved dose (1 mg), based on historical data, and thus considered to be therapeutically equivalent.
This study consists of the screening period, treatment period, and the follow-up period. Both study parts are independent and can be run simultaneously.REC name
North East - York Research Ethics Committee
REC reference
14/NE/1189
Date of REC Opinion
28 Nov 2014
REC opinion
Further Information Favourable Opinion