NCT04426474

Brief Summary

The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2020

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

June 8, 2020

Last Update Submit

July 26, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Baseline through Follow-up (up to Day 105)

Secondary Outcomes (4)

  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

    Day 1 through Day 84: Predose up to 96 hours postdose

  • PK: Area Under the Concentration Versus Time Curve of LY3502970

    Day 1 through Day 84: Predose up to 96 hours postdose

  • Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)

    Baseline, Week 12

  • PD: Change from Baseline to Week 12 in Fasting Insulin

    Baseline, Week 12

Study Arms (2)

LY3502970

EXPERIMENTAL

LY3502970 administered orally.

Drug: LY3502970

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY3502970DRUG

Administered orally.

LY3502970
PlaceboDRUG

Administered orally.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have type 2 diabetes mellitus (T2DM) for at least 6 months
  • Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
  • Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive
  • Have had a stable body weight for the 3 months prior to screening (less than \[\<\]5% body weight change)
  • Males and females (not considered woman of childbearing potential)

You may not qualify if:

  • Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
  • Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
  • Show evidence of hepatitis B, and/or positive hepatitis B surface antigen
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Any glucose-lowering medications other than metformin within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Midwest Clinical Research Unit

Dayton, Ohio, 45417, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Location

Profil Mainz

Mainz, 55116, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

October 8, 2020

Primary Completion

July 12, 2021

Study Completion

July 12, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)DE(2)