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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

Study Summary

This trial is investigating the safety and tolerability of a new diabetes drug given alone or with another diabetes medication. Blood tests will be done to see how the drug affects the body. The trial will last up to 16 weeks and include up to 17 visits.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on day 1 up to 85 days post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on day 1 up to 85 days post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
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
2,615 Previous Clinical Trials
3,200,964 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,158 Total Patients Enrolled

Media Library

LY3457263 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05377333 — Phase 1
Type 2 Diabetes Research Study Groups: LY3457263 (Alone), Placebo (Alone), LY3457263 + Dulaglutide, Placebo + Dulaglutide
Type 2 Diabetes Clinical Trial 2023: LY3457263 Highlights & Side Effects. Trial Name: NCT05377333 — Phase 1
LY3457263 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377333 — Phase 1
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05377333 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this research protocol?

"According to clinicaltrials.gov, this medical experiment is in search of participants and has been actively updated since June 2nd 2022. The most recent edit was on October 10th 2022."

Answered by AI

How many people are receiving treatment in this research endeavor?

"To fulfill the clinical trial's requirements, 86 suitable subjects must be enrolled. Eli Lilly and Company are coordinating this research from two locations: Qps-Mra, Llc in South Miami, Florida; and CenExcel ACT in Anaheim California."

Answered by AI

Does the study accept participants below a certain age threshold?

"This trial has an age requirement, with the minimum being 20 and the maximum set at 75."

Answered by AI

What is the geographic scope of this experiment?

"For this research endeavour, there are 5 different operating centres. These include Qps-Mra, Llc in South Miami, CenExcel ACT in Anaheim and Pinnacle Research Group, LLC situated in Anniston; among others."

Answered by AI

What potential hazards are associated with LY3457263?

"The safety of LY3457263 is granted a score of 1, as the clinical trial has only entered Phase 1 and thus lacks substantial evidence in regards to efficacy or potential risks."

Answered by AI

Who would be considered an ideal candidate for involvement in this experiment?

"This medical trial is enrolling 86 individuals aged between 20 and 75 that suffer from Type 2 diabetes Mellitus (T2D). Applicants must have managed their condition with diet and exercise, potentially in combination with metformin, for a minimum of 6 months prior to screening. In addition, they must have an HbA1c level ranging between 7.5% and 10.5%, maintained stable body weight over the course of 3 months at a BMI rate of 27-45 kg/m²; male patients are expected to use effective forms contraception whereas females should be incapable of childbearing."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
California
How old are they?
65+
What site did they apply to?
CenExcel ACT
CenExel-HRI
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

How Long is The Trial for?
PatientReceived no prior treatments

Why did patients apply to this trial?

I am Interested in Trying Different Drugs to Help with Type 2 Diabetes......
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
2022. "A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05377333.
~33 spots leftby Apr 2025
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