Profil Institut für Stoffwechselforschung
Neuss, 41460, Germany
Location status: Recruiting
NCT Number: NCT06280703
The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec.
The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected.
The study will be conducted in four parts (A, B, C, and D). Healthy participants in Part A Period 1 will receive a single dose of LY3938577 or a placebo given via intravenous (IV) infusion. In Part A Period 2, participants will receive a single subcutaneous (SC) dose of either LY3938577 or placebo. Participants in Part B with Type 1 Diabetes Mellitus (T1DM) will receive single doses of either LY3938577 or Insulin Degludec given via IV infusion. Participants in Part C with Type 1 Diabetes Mellitus (T1DM) will receive two doses of either LY3938577 or Insulin Degludec administered SC. Participants in Part D with Type 1 Diabetes Mellitus (T1DM) will be evaluated in 2 periods, with Period 1 administered pre-study basal insulin and lispro mealtime insulin to establish insulin needs, and Period 2 administered lispro mealtime insulin and daily doses of LY3938577.
The study will last up to approximately 11 weeks for Part A, 10 weeks for Part B, 13 weeks for Part C, and 10 weeks for Part D , including screening period.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part A -
Parts B and C -
Part D -
All Parts -
Exclusion criteria
Parts B, C, and D -
Parts B and C -
Part D -
All Parts -
Administered Intravenously (IV)
Administered Intravenously (IV)
Administered Intravenously (IV)
Administered Intravenously (IV)
Administered subcutaneously (SC)
Administered subcutaneously (SC)
Time frame: Baseline up to Approximately Week 11
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Time frame: Baseline up to Week 10
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Time frame: Baseline up to Approximately Week 11
Time frame: Baseline up to Week 10
Time frame: Baseline up to Approximately Week 11
Time frame: Baseline up to Week 10
Time frame: Predose on day 1 up to week 13 post dose
PK: AUC of LY3938577 for intravenous administration
Time frame: Predose on day 1 up to week 13 post dose
PK: AUC of LY3938577 for SC administration
Time frame: Predose on day 1 up to week 13 post dose
PK: AUC of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
PK: AUC of LY3938577 for SC administration
Time frame: Predose on day 1 up to week 13 post dose
PK: AUC of LY3938577 for SC administration
Time frame: Predose on day 1 up to week 13 post dose
PK: Cmax of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
PK: Cmax of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
Time frame: Predose up to day 14 post dose
Measured at different glucose levels in participants with T1DM
Time frame: Predose up to day 14 post dose
Measured at different glucose levels in participants with T1DM
Contact information is provided by the study sponsor or research team.
Physicians interested in becoming principal investigators please contact
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Eli Lilly and Company
Industry
A Four-Part, Randomized, Double-Blind (Part A) and Open-Label (Part B, Part C, and Part D), Multi-Dose, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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