What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes Mellitus, such as GLP-1 receptor agonists (e.g., exenatide, liraglutide) and SGLT2 inhibitors, have several known side effects. GLP-1 receptor agonists can cause gastrointestinal issues like nausea, vomiting, and diarrhea, and have been associated with an increased risk of pancreatitis. SGLT2 inhibitors may lead to urinary tract infections, genital infections, and an increased risk of amputations. Both classes of drugs have shown cardiovascular benefits but require careful monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes Mellitus that are similar to LY3938577. These include GLP-1 receptor agonists such as liraglutide and extended-release exenatide, which have been shown to improve glycemic control and have additional benefits like modest weight loss. Liraglutide was approved for pediatric use based on the ELLIPSE trial, and extended-release exenatide was approved following a trial demonstrating improved glycemic control in adolescents. Additionally, dulaglutide, another GLP-1 receptor agonist, has been approved for use in children and adolescents with T2DM.

What other types of research exist?

Promising novel alternatives to LY3938577 for T2DM treatment include: <ol> <li>Taspoglutide - a GLP-1 agonist.</li> <li></li> </ol> SKL-18287 - a GLP-1 analog. 3. MB07803 - a second-generation fructose-1,6-bisphosphatase (FBPase) inhibitor. 4. Tirzepatide - a dual GIP and GLP-1 receptor agonist. 5. SHR0534 - a GPR40 agonist. These drugs have shown potential in clinical trials and may offer effective glycemic control for T2DM patients.

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Monoclonal Antibodies

LY3938577 for Type 2 Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes include GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, and thiazolidinediones. GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release, improving blood glucose control and promoting weight loss. SGLT2 inhibitors reduce blood glucose by preventing glucose reabsorption in the kidneys, leading to its excretion in urine. DPP-4 inhibitors prolong the action of incretin hormones, which increase insulin release and decrease glucagon levels. Thiazolidinediones improve insulin sensitivity by acting on fat cells to increase glucose uptake. These mechanisms are crucial for Type 2 Diabetes patients as they target different aspects of glucose regulation, offering comprehensive management of the disease.

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

Male or female participants of nonchildbearing potential

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

Must not have

Have proliferative retinopathy or maculopathy and/or severe neuropathy

Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 44 days

Summary

This trial tests a new drug, LY3938577, to see if it is safe for healthy people and those with Type 2 Diabetes. The study will check how well people tolerate the drug over several weeks.

Who is the study for?

This trial is for healthy adults and those with Type 2 Diabetes Mellitus (T2DM). Healthy participants should have a BMI of 18.5-32 kg/m², while T2DM participants can have up to 40 kg/m². T2DM should be diagnosed over a year ago. People with severe eye or nerve complications, recent steroid therapy, or participation in another study recently cannot join.

What is being tested?

The safety and tolerability of LY3938577 are being tested on two groups: healthy individuals and those with T2DM. Part A involves a single dose for both types of participants; Part B gives multiple doses to only the T2DM group. The study compares LY3938577 against Insulin degludec and placebo over approximately six to ten weeks.

What are the potential side effects?

While specific side effects aren't listed here, common ones from diabetes medications may include low blood sugar levels, weight gain, nausea, injection site reactions, headache, upper respiratory tract infections and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot become pregnant or get someone pregnant.

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My BMI is within the required range for my health status.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe eye or nerve problems.

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I have been treated with diabetes medication in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 44 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 44 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 44 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: LY3938577 (Part B)Experimental Treatment1 Intervention

LY3938577 administered SC.

Group II: LY3938577 (Part A)Experimental Treatment1 Intervention

LY3938577 administered Subcutaneously (SC).

Group III: Insulin degludec (Part A)Active Control1 Intervention

Insulin degludec administered SC.

Group IV: Insulin degludec (Part B)Active Control1 Intervention

Insulin degludec administered SC.

Group V: Placebo (Part A)Placebo Group1 Intervention

Placebo administered SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3938577

2023

Completed Phase 1

~70

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, and thiazolidinediones. GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release, improving blood glucose control and promoting weight loss. SGLT2 inhibitors reduce blood glucose by preventing glucose reabsorption in the kidneys, leading to its excretion in urine. DPP-4 inhibitors prolong the action of incretin hormones, which increase insulin release and decrease glucagon levels. Thiazolidinediones improve insulin sensitivity by acting on fat cells to increase glucose uptake. These mechanisms are crucial for Type 2 Diabetes patients as they target different aspects of glucose regulation, offering comprehensive management of the disease.

Assessing the quality of the evidence underlying recommendations in type 2 diabetes' commonly used clinical practice guidelines.Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.Combination therapy for the improvement of long-term macrovascular and microvascular outcomes in type 2 diabetes: Rationale and evidence for early initiation.