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LY3457263 + Dulaglutide for Type 2 Diabetes
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose on day 1 up to 85 days post-dose
Awards & highlights
Summary
This trial is testing a new drug called LY3457263, alone or with another diabetes medication, in people with type 2 diabetes. Researchers will use blood tests to check if the drug is safe and how it affects the body.
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose on day 1 up to 85 days post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on day 1 up to 85 days post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary study objectives
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo + DulaglutideExperimental Treatment2 Interventions
Placebo in combination with dulaglutide administered SC.
Group II: LY3457263 + DulaglutideExperimental Treatment2 Interventions
LY3457263 in combination with dulaglutide administered SC.
Group III: LY3457263 (Alone)Experimental Treatment1 Intervention
LY3457263 administered subcutaneously (SC).
Group IV: Placebo (Alone)Placebo Group1 Intervention
Placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
2017
Completed Phase 4
~6630
LY3457263
2022
Completed Phase 1
~200
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,550 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,996 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.You have a history or current condition affecting your heart, lungs, liver, kidneys, digestive system, hormones (except T2D), blood, or nervous system that could affect how drugs are absorbed, processed, or removed from your body.You are allergic to GLP-1 receptor agonists.You have type 2 diabetes (T2D) at least 6 months before screening.You have a body mass index (BMI) of 27.0 to 45.You are male and you agree to use effective methods of contraception.
Research Study Groups:
This trial has the following groups:- Group 1: LY3457263 (Alone)
- Group 2: Placebo (Alone)
- Group 3: LY3457263 + Dulaglutide
- Group 4: Placebo + Dulaglutide
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05377333 — Phase 1
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