Retatrutide for Chronic Kidney Disease and Obesity

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Must be taking: Oral antihyperglycemics, Basal insulin

Must not be taking: DPP4 inhibitors, GLP-RA, Rapid insulins

Disqualifiers: Obesity surgery, Type 1 diabetes, Hepatitis, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that if you have Type 2 Diabetes, you should be on stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin, for at least 90 days before screening. Certain diabetes medications like DPP4 inhibitors and rapid-acting insulins should not have been used in the 90 days before screening.

What data supports the effectiveness of the drug Retatrutide for chronic kidney disease and obesity?

Research shows that Retatrutide, which targets specific receptors involved in metabolism, has been effective in lowering blood sugar and body weight in people with type 2 diabetes. Additionally, similar drugs that target GLP-1 receptors have shown benefits for kidney function in diabetes patients. ^{1 2 3 4 5}

Is Retatrutide safe for humans?

Retatrutide has been studied for safety in people with type 2 diabetes and obesity. In these studies, it was generally well-tolerated, but like any medication, it may have side effects. Always discuss potential risks with your doctor. ^{1 2 3 6 7}

How is the drug Retatrutide unique for treating chronic kidney disease and obesity?

Retatrutide is unique because it targets three different hormone receptors (GLP-1, GIP, and glucagon) in one drug, which may help manage both obesity and related conditions like type 2 diabetes more effectively than treatments targeting only one or two of these receptors. ^{1 2 3 6 8}

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with chronic kidney disease.

My diabetes is under control with diet, exercise, or up to 3 medications.

Have a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)

Exclusion Criteria

I have lost or gained more than 11 pounds in the last 3 months.

I have hepatitis.

I have had or am planning to have surgery for weight loss.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of retatrutide or placebo subcutaneously

24 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Retatrutide (LY3437943) (GLP-1 Receptor Agonist)

Trial Overview 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.

Participant Groups

Group I: Retatrutide Experimental Treatment 1 Intervention

Participants will receive multiple doses of retatrutide subcutaneously (SC)

Group II: Placebo Placebo Group 1 Intervention

Participants will receive LY3437943

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Care Access - 801 South Power Road, Mesa Mesa, AZ

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa Chandler, AZ

Centricity Research Brampton Endocrinology Brampton, Canada

Diex Recherche Joliette Joliette, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA. [2023] According to current consensus guidelines for type 2 diabetes management, bodyweight management is as important as attaining glycaemic targets. Retatrutide, a single peptide with agonist activity at the glucose-dependent insulinotropic polypeptide (GIP), GLP-1, and glucagon receptors, showed clinically meaningful glucose-lowering and bodyweight-lowering efficacy in a phase 1 study. We aimed to examine the efficacy and safety of retatrutide in people with type 2 diabetes across a range of doses.

2. England pubmed.ncbi.nlm.nih.gov

Retatrutide showing promise in obesity (and type 2 diabetes). [2023] Obesity is a major risk factor for cardiovascular disease, diabetes, osteoarthritis, and some cancers. Retatrutide stimulates Glucagon-like peptide 1 (GLP-1), Glucose-dependent insulinotropic polypeptide (GIP) receptors, and glucagon receptors, and is being developed for the treatment of obesity and type 2 diabetes.

3. United States pubmed.ncbi.nlm.nih.gov

Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. [2023] Retatrutide (LY3437943) is an agonist of the glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and glucagon receptors. Its dose-response relationships with respect to side effects, safety, and efficacy for the treatment of obesity are not known.

4. Japan pubmed.ncbi.nlm.nih.gov

Effects of glucagon-like peptide-1 receptor agonists on kidney function and safety in type 2 diabetes patients. [2021] Glucagon-like peptide-1 receptor agonists have been recommended in diabetic kidney disease patients.

5. England pubmed.ncbi.nlm.nih.gov

Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial. [2020] Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease.

6. England pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. [2022] Treating hyperglycaemia and obesity in individuals with type 2 diabetes using multi-receptor agonists can improve short-term and long-term outcomes. LY3437943 is a single peptide with agonist activity for glucagon, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-1) receptors that is currently in development for the treatment of type 2 diabetes and for the treatment of obesity and associated comorbidities. We investigated the safety, pharmacokinetics, and pharmacodynamics of multiple weekly doses of LY3437943 in people with type 2 diabetes in a 12-week study.

7. England pubmed.ncbi.nlm.nih.gov

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] LY3298176 is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that is being developed for the treatment of type 2 diabetes. We aimed to examine the efficacy and safety of co-stimulation of the GLP-1 and GIP receptors with LY3298176 compared with placebo or selective stimulation of GLP-1 receptors with dulaglutide in patients with poorly controlled type 2 diabetes.

8. Germany pubmed.ncbi.nlm.nih.gov

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] A novel dual GIP and GLP-1 receptor agonist, LY3298176, was developed to determine whether the metabolic action of GIP adds to the established clinical benefits of selective GLP-1 receptor agonists in type 2 diabetes mellitus (T2DM).