* A Multiple Dose Study of LY3502970 in Healthy Participants (QSC202755)
Research type
Research Study
Full title
A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
IRAS ID
292540
Contact name
Carly Anderson
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-005750-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
142842, IND
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
The Sponsor is developing a new test medicine (LY3502970) to treat type 2 diabetes. Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high. It can cause serious, potentially life-threatening complications.
The study will try to characterise and compare how the test medicine is taken up by the body (pharmacokinetics) when given in different recipes (formulations). It will also assess the safety and tolerability of the test medicine and the effect of different administration conditions.
The study will consist of two parts (Part A and Part B), involving up to 24 healthy male and female volunteers of non-childbearing potential, 12 in each part. In both parts volunteers will enter the clinical unit on Day -1. Volunteers will receive multiple doses of the reference and test medicines from Day 1 to Day 36. Different formulations of the test medicine will be given throughout this time. Volunteers will remain on site until discharge on Day 41 and will return to the clinical unit for a follow-up visit between 7 and 17 days after the final dose, to check their continued wellbeing.
Part B may be used to further investigate the formulations used in Part A, in different administration conditions. These conditions will include in the fed vs the fasted state, and the impact of a proton pump inhibitor (a medication to reduce stomach acid production). Alternatively, Part B may assess additional formulations.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0195
Date of REC Opinion
21 Apr 2021
REC opinion
Further Information Favourable Opinion