What side effects are associated with this type of intervention?

Treatments for Chronic Kidney Disease (CKD) similar to CagriSema, which combines a GLP-1 receptor agonist and an amylin analog, commonly include medications like semaglutide and pramlintide. These treatments are known to cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. They may also lead to decreased appetite and weight loss. Additionally, amylin analogs can cause hypoglycemia, particularly when used in conjunction with insulin. Despite these side effects, these medications have demonstrated benefits in reducing cardiovascular events and improving renal outcomes.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Kidney Disease (CKD) that are similar to the investigational combination in the CagriSema trial include GLP-1 receptor agonists such as liraglutide and semaglutide. These drugs have demonstrated efficacy in improving glycemic control, reducing weight, and providing cardiovascular benefits, which are crucial for CKD patients. Liraglutide, for instance, has shown renal protective effects by reducing albuminuria. While amylin analogs like pramlintide are used to manage blood glucose levels, their specific approval for CKD treatment is not well-documented. Overall, GLP-1 receptor agonists are a key component in managing CKD in patients with type 2 diabetes and obesity.

What other types of research exist?

Promising alternatives to CagriSema for CKD patients include GLP-1 receptor agonists like semaglutide and liraglutide, and SGLT2 inhibitors such as empagliflozin and canagliflozin. These treatments have shown efficacy in managing blood glucose levels, reducing weight, and providing renal benefits.

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CagriSema for Chronic Kidney Disease and Type 2 Diabetes in Obesity

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

Common treatments for Chronic Kidney Disease (CKD) include GLP-1 receptor agonists and amylin analogs, which are particularly relevant for patients with type 2 diabetes and obesity. GLP-1 receptor agonists, such as semaglutide, work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, thereby improving blood glucose control and promoting weight loss. Amylin analogs, like cagrilintide, help regulate postprandial glucose levels and increase satiety. These mechanisms are vital for CKD patients as they address key risk factors—diabetes and obesity—thereby potentially slowing the progression of kidney damage.

Phase 2

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening

Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 milliliters per minutes per 1.73^m^2 (mL/min/1.73 m^2) (CKD-EPI 2021) as assessed by central laboratory at screening

Must not have

Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to end of study (week 32)

Summary

This trial is testing a new medicine called CagriSema to see if it can reduce kidney damage in people with chronic kidney disease, type 2 diabetes, and who are overweight or obese. The study will compare CagriSema to two other medicines.

Who is the study for?

Adults over 18 with chronic kidney disease, type 2 diabetes, and a BMI of at least 27 can join this study. They must have some kidney function left (eGFR ≥15 to <90), not be on dialysis, and have been treated with specific blood pressure meds for at least a month. Pregnant women or those planning pregnancy are excluded.

What is being tested?

The trial is testing CagriSema against Semaglutide, Cagrilintide, and placebo in reducing kidney damage for people with CKD and T2D who are overweight. Treatments are assigned randomly like flipping a coin, and neither participants nor doctors know which one they get.

What are the potential side effects?

Potential side effects may include digestive issues such as nausea or diarrhea due to the nature of these medications affecting glucose metabolism but will vary based on individual reactions.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is 27 or higher.

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My kidney function is reduced but not severely impaired.

Exclusion Criteria

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

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I have a genetic or autoimmune kidney disease, like polycystic kidney disease or glomerulonephritis.

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I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of study (week 32)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to end of study (week 32)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 32) 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 in urinary albumin-to-creatinine ratio (UACR)

Secondary study objectives

Achievement of greater than or equal to (≥) 5 % weight reduction

Achievement of ≥ 10 % weight reduction

Change in diastolic blood pressure

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Semaglutide 2.4 mgExperimental Treatment2 Interventions

Participants will receive semaglutide 2.4 mg and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.

Group II: Cagrilintide 2.4 mgExperimental Treatment2 Interventions

Participants will receive cagrilintide 2.4 mg and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.

Group III: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions

Participants will receive 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive 2.4 mg placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cagrilintide

2023

Completed Phase 1

~150

Semaglutide

2021

Completed Phase 4

~5160

Placebo

1995

Completed Phase 3

~2670

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 Chronic Kidney Disease (CKD) include GLP-1 receptor agonists and amylin analogs, which are particularly relevant for patients with type 2 diabetes and obesity. GLP-1 receptor agonists, such as semaglutide, work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, thereby improving blood glucose control and promoting weight loss. Amylin analogs, like cagrilintide, help regulate postprandial glucose levels and increase satiety. These mechanisms are vital for CKD patients as they address key risk factors—diabetes and obesity—thereby potentially slowing the progression of kidney damage.

Prescribing SGLT2 Inhibitors in Patients With CKD: Expanding Indications and Practical Considerations.Inhibition of notch signalling and mesangial expansion by combined glucagon like peptide-1 agonist and crocin therapy in animal model of diabetic nephropathy.Effect of lipo-prostaglandin E1 on cystatin C, β2-microglobulin, and estimated glomerular filtration rate in patients with decompensated heart failure and renal dysfunction: a single-center, nonrandomized controlled study.