Clinical trial NCT06132126: A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Official title: A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-11-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.


Eligibility criteria: Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
* Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
* Have a body mass index within the range of 18.5 to less than or equal to (\<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
* Male or female participants of nonchildbearing potential

Exclusion Criteria:

* Have proliferative retinopathy or maculopathy and/or severe neuropathy
* Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
* Have received chronic systemic glucocorticoid therapy in the past 3 months
* Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.

Primary outcomes:
measure: 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
timeFrame: Baseline up to 16 days
measure: 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
timeFrame: Baseline up to 44 days
measure: Part A: Incidence of Hypoglycemia
timeFrame: Baseline up to 16 days
measure: Part B: Incidence of Hypoglycemia
timeFrame: Baseline up to 44 days
measure: Part A: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline up to 16 days
measure: Part B: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline up to 44 days
measure: Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
timeFrame: Baseline up to 16 days
measure: Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
timeFrame: Baseline up to 44 days
Secondary outcomes:
measure: Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)
timeFrame: Part A: Predose up to 16 Days and Part B: Predose up to 44 Days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CenExel ACT
state: California
city: Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Dallas
country: United States
facility: Labcorp CRU
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: