A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132126
• Other study ID #: 18779
• Secondary ID: J4P-MC-IYAA
• Status: Recruiting
• Phase: Phase 1
• Start date: November 17, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LY3938577
Administered SC.
• Placebo
Administered SC.
• Insulin degludec
Administered SC.

Locations

Country	Name	City	State
United States	CenExel ACT	Anaheim	California
United States	Labcorp CRU	Dallas	Texas
United States	Qps-Mra, Llc	Miami	Florida
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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
Primary	Part A: Incidence of Hypoglycemia		Baseline up to 16 days
Primary	Part B: Incidence of Hypoglycemia		Baseline up to 44 days
Primary	Part A: Number of Participants With Clinically Significant Changes in Vital Signs		Baseline up to 16 days
Primary	Part B: Number of Participants With Clinically Significant Changes in Vital Signs		Baseline up to 44 days
Primary	Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters		Baseline up to 16 days
Primary	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

External Links

•   A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus