| Trial ID: | L2348 |
| Source ID: | NCT06132126
|
| Associated Drug: |
Ly3938577
|
| Title: |
A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Healthy|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: LY3938577|DRUG: Placebo|DRUG: Insulin degludec
|
| Outcome Measures: |
Primary: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module., Baseline up to 16 days|Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module., Baseline up to 44 days|Part A: Incidence of Hypoglycemia, Baseline up to 16 days|Part B: Incidence of Hypoglycemia, Baseline up to 44 days|Part A: Number of Participants With Clinically Significant Changes in Vital Signs, Baseline up to 16 days|Part B: Number of Participants With Clinically Significant Changes in Vital Signs, Baseline up to 44 days|Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, Baseline up to 16 days|Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, Baseline up to 44 days | Secondary: Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC), Part A: Predose up to 16 Days and Part B: Predose up to 44 Days
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
66
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2023-11-17
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| Completion Date: |
2024-06-28
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| Results First Posted: |
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| Last Update Posted: |
2024-07-24
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| Locations: |
CenExel ACT, Anaheim, California, 92801, United States|Qps-Mra, Llc, Miami, Florida, 33143, United States|Labcorp CRU, Dallas, Texas, 75247, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06132126
|
