NCT05407961CompletedPhase 1
A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus
A Phase 1b, 2-Part, Investigator- and Participant-Blind, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3532226 in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 29 Mar 2024
Brief summary (registry, in English)
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 26 May 2022
- Start date
- 7 Jun 2022
- Primary completion date
- 12 Jan 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05407961
- EudraCT number
- 2021-003257-31
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 90
- From 7 Jun 2022 to the primary completion date, 12 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
- Have received chronic systemic glucocorticoid therapy (\>2 weeks) in the past 6 months
Other illness
- Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome
Lab values
- Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or DPP4
Age
- Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older)
Other
- Have a clinically significant abnormality ECG
- Smoke more than 10 cigarettes, or cigarette equivalent, per day
Who the study is looking for
- Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
- Have the following glycosylated hemoglobin (HbA1c) levels at screening:
- HbA1c \>/= 7.0% to \</= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and
- HbA1c \>/= 6.0% to \</= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor
- Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
- Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Profil Institut für Stoffwechselforschung Coordinator of this site? Confirm its status | Neuss | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.