What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as liraglutide, exenatide, dulaglutide, and semaglutide, are commonly used in the treatment of Type 2 Diabetes. Known side effects include gastrointestinal issues like nausea, vomiting, and diarrhea. There is also a potential risk for benign and malignant thyroid C cell tumors, as observed in rodent studies, although this risk is not well-established in humans. Additionally, these medications can cause weight loss, which may be beneficial for some patients. They are generally not recommended for individuals with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2A or 2B.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of Type 2 Diabetes, which are similar to Retatrutide in their mechanism of action. These include liraglutide, exenatide, dulaglutide, and semaglutide. These drugs improve glycemic control by enhancing glucose-dependent insulin secretion, delaying gastric emptying, regulating postprandial glucagon, and reducing food intake. Additionally, they have shown benefits in weight management and renal protection. For instance, liraglutide and semaglutide have demonstrated cardiovascular benefits and reduced the risk of diabetic kidney disease progression. However, these drugs may have side effects such as gastrointestinal symptoms and, in rare cases, an increased risk of pancreatitis.

What other types of research exist?

Promising alternatives to Retatrutide for Type 2 Diabetes patients include other GLP-1 receptor agonists such as liraglutide, semaglutide, and dulaglutide. These agents improve glycemic control, aid in weight management, and have shown cardiovascular and renal benefits. Additionally, sodium-glucose co-transporter 2 inhibitors (SGLT2-i) like empagliflozin and canagliflozin are also promising due to their cardiovascular and renal protective effects.

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GLP-1 Receptor Agonist

Retatrutide for Chronic Kidney Disease and Obesity

Phase 2

Recruiting

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 baseline, week 24

Summary

This trial is testing a medication called retatrutide to see if it can help improve kidney function. The study focuses on people who are overweight or obese and have chronic kidney disease, with or without Type 2 Diabetes. The goal is to find out if this medication can make their kidneys work better.

Who is the study for?

This trial is for adults with overweight or obesity and chronic kidney disease, with or without Type 2 Diabetes. Participants must have a BMI ≥27 kg/m², stable treatment for at least 90 days, and specific HbA1c levels depending on their diabetes status. Exclusions include recent significant weight change, certain diabetes medications within the last 90 days, and a history of cancer in the past five years.

What is being tested?

The study tests Retatrutide (LY3437943) to see its effects on kidney function in people who are overweight or obese with chronic kidney disease. Some participants will receive LY3437943 while others will get a placebo (a substance with no active drug). The trial lasts approximately 31 weeks.

What are the potential side effects?

While not specified here, common side effects from similar drugs may include gastrointestinal symptoms like nausea or vomiting, potential allergic reactions, injection site reactions if applicable, and possibly changes in blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Glomerular Filtration Rate (mGFR)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RetatrutideExperimental Treatment1 Intervention

Participants will receive multiple doses of retatrutide subcutaneously (SC)

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive LY3437943

Do I qualify?Apply below to find out

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

GLP-1 receptor agonists, such as liraglutide, exenatide, and dulaglutide, mimic the incretin hormone GLP-1, which is released after eating. These medications enhance glucose-dependent insulin secretion, delay gastric emptying, regulate postprandial glucagon, and reduce food intake, leading to improved glycemic control and weight management. For Type 2 Diabetes patients, these mechanisms are crucial as they help in maintaining blood glucose levels, reducing the risk of cardiovascular events, and potentially improving renal function by reducing inflammation and improving metabolic parameters.

GLP-1RAs in type 2 diabetes: mechanisms that underlie cardiovascular effects and overview of cardiovascular outcome data.The Cardiovascular Biology of Glucagon-like Peptide-1.