38 Participants Needed

A Study of LY3457263 in Obese Participants

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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called LY3457263 together with tirzepatide to see if they are safe and well-tolerated in overweight or obese people. The study will also measure how much of LY3457263 gets into the bloodstream and how long it stays in the body. The trial will last a few months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves evaluating new medications, it's possible that some changes to your current medication regimen might be required. Please consult with the trial coordinators for specific guidance.

How is the drug LY3457263 (Tirzepatide) different from other treatments for type 2 diabetes?

LY3457263 (Tirzepatide) is unique because it is a dual agonist, meaning it activates both GIP and GLP-1 receptors, which can enhance insulin release and improve blood sugar control more effectively than treatments targeting only GLP-1 receptors.12345

What data supports the effectiveness of the drug LY3457263?

Research shows that tirzepatide, a component of LY3457263, is effective in lowering blood sugar levels and body weight in people with type 2 diabetes. It works by activating two hormones that help control blood sugar and appetite.678910

Who Is on the Research Team?

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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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Inclusion Criteria

You are male or female.
Participants who are overtly healthy as determined by medical evaluation
Your weight and body mass index (BMI) fall within a specific range of 27.0 to 45.0 kilograms per meter squared (kg/m²).

Exclusion Criteria

Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements
Have an abnormal 12-lead electrocardiogram (ECG) at screening
Have type 1 or type 2 diabetes mellitus

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple doses of LY3457263 in combination with tirzepatide

6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY3457263
  • Placebo
  • Tirzepatide
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3457263 + TirzepatideExperimental Treatment2 Interventions
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
Group II: Placebo + TirzepatidePlacebo Group2 Interventions
Placebo administered SC in combination with tirzepatide given SC.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.
Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.
Tirzepatide: Clinical review of the "twincretin" injectable.Krauss, Z., Hintz, A., Fisk, R.[2023]
Tirzepatide, a medication for type 2 diabetes, shows a dose-dependent increase in gastrointestinal adverse events (AEs), with nausea and diarrhea being the most common, affecting up to 49% of participants at the highest dose (15 mg).
Despite the gastrointestinal side effects, serious adverse events like severe hypoglycemia and acute pancreatitis are rare (≤ 1%), indicating that tirzepatide is generally safe for use in patients with type 2 diabetes.
Adverse Events Related to Tirzepatide.Mishra, R., Raj, R., Elshimy, G., et al.[2023]
In a study involving 2002 adults with type 2 diabetes and high cardiovascular risk, tirzepatide significantly reduced HbA1c levels more than insulin glargine after 52 weeks, with reductions of -2.43% and -2.58% for tirzepatide 10 mg and 15 mg, respectively, compared to -1.44% for glargine.
Tirzepatide was associated with a lower incidence of hypoglycemia (6-9%) compared to glargine (19%), and it did not increase cardiovascular risk, showing it is a safe and effective option for managing diabetes in high-risk patients.
Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.Del Prato, S., Kahn, SE., Pavo, I., et al.[2022]

Citations

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]
Adverse Events Related to Tirzepatide. [2023]
Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial. [2022]
The importance of glucose-dependent insulinotropic polypeptide receptor activation for the effects of tirzepatide. [2023]
Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. [2022]
LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. [2021]
Genetically Predicted Glucose-Dependent Insulinotropic Polypeptide (GIP) Levels and Cardiovascular Disease Risk Are Driven by Distinct Causal Variants in the GIPR Region. [2022]
Enhanced agonist residence time, internalization rate and signalling of the GIP receptor variant [E354Q] facilitate receptor desensitization and long-term impairment of the GIP system. [2021]
Localization of glucose-dependent insulinotropic polypeptide (GIP) to a gene cluster on chromosome 17q. [2007]
Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. [2022]
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