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NCT06132126CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 24 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
66 (actual)
First submitted
10 Nov 2023
Start date
17 Nov 2023
Primary completion date
28 Jun 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT06132126

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 66
  • From 17 Nov 2023 to the primary completion date, 28 Jun 2024
  • 3 sites 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

  • 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.

Other

  • Have proliferative retinopathy or maculopathy and/or severe neuropathy

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CenExel ACT
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status
Labcorp CRU
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Qps-Mra, Llc.
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.