What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as semaglutide, are commonly associated with gastrointestinal side effects, including nausea, vomiting, and diarrhea. They may also increase the risk of pancreatitis and, in rare cases, diabetic retinopathy. Amylin analogs, like cagrilintide, can also cause gastrointestinal issues, particularly nausea. Both classes of drugs are generally well-tolerated but require monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of Type 2 Diabetes, including semaglutide, liraglutide, and exenatide. These drugs help improve glycemic control and promote weight loss. Semaglutide, for instance, is available in both weekly and daily formulations. Liraglutide has also been approved for pediatric use in patients aged 10 and older. Amylin analogs, such as pramlintide, have been approved to assist in glycemic control by slowing gastric emptying and promoting satiety. The combination of these drug classes, as seen in the CagriSema trial, aims to enhance efficacy in managing blood sugar levels and body weight.

What other types of research exist?

Promising alternatives to CagriSema for Type 2 Diabetes patients include: 1) Semaglutide alone, which has shown significant weight loss and cardiovascular benefits. 2) Dulaglutide, another GLP-1 receptor agonist, which has demonstrated efficacy in glycemic control and weight management. 3) SGLT2 inhibitors, which not only improve glycemic control but also offer cardiovascular and renal benefits. 4) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown superior efficacy in glycemic control and weight loss compared to existing GLP-1 RAs.

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GLP-1 Receptor Agonist

CagriSema for Type 2 Diabetes (REIMAGINE 2 Trial)

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

GLP-1 receptor agonists, such as semaglutide, enhance glucose-dependent insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety, aiding in blood sugar control and weight loss. Amylin analogs, like cagrilintide, complement these effects by also slowing gastric emptying, suppressing postprandial glucagon secretion, and increasing satiety. These mechanisms are crucial for Type 2 Diabetes patients as they address both hyperglycemia and obesity, common comorbidities in these patients.

Verified Trial

Phase 3

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

Stable daily dose(s) greater than or equal to 90 days before screening of metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors at effective or maximum tolerated dose as judged by the investigator

Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening

Must not have

Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by central laboratory at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week -3) to end of treatment (week 68)

Awards & highlights

Pivotal Trial

Summary

This trial tests CagriSema, a combination of semaglutide and cagrilintide, in people with type 2 diabetes. It aims to see if it can better manage blood sugar levels and reduce body weight by increasing insulin and reducing hunger. Semaglutide is known for lowering blood glucose levels and reducing appetite.

Who is the study for?

This trial is for adults with type 2 diabetes who have been diagnosed for at least 180 days, have an HbA1c level of 7.0-10.5%, and are on a stable dose of metformin with or without SGLT2 inhibitors. Participants should also have a BMI of at least 25 kg/m^2. Those with severe kidney issues, unstable diabetic eye disease, or recent use of other diabetes/obesity meds (except short-term insulin) cannot join.

What is being tested?

The study tests CagriSema—a combination drug including semaglutide and cagrilintide—against each component alone and a placebo to see how well it lowers blood sugar and body weight in people taking their usual diabetes medication.

What are the potential side effects?

Potential side effects may include digestive discomfort like nausea or diarrhea, possible allergic reactions, changes in appetite, low blood sugar events especially if combined with other diabetes medications, and injection site reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been on a stable dose of metformin, with or without SGLT2 inhibitors, for over 90 days.

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My BMI is 25 or higher.

Exclusion Criteria

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

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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week -3) to end of treatment (week 68)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week -3) to end of treatment (week 68)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -3) to end of treatment (week 68) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c)

CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight

Secondary study objectives

CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)

CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of severe hypoglycaemic episodes (level 3)

CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of treatment emergent adverse events (TEAEs)

+33 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions

Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Group II: CagriSema 1.0 mg/1.0 mgExperimental Treatment2 Interventions

Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Group III: Cagrilintide 2.4 mgActive Control1 Intervention

Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.

Group IV: Semaglutide 1.0 mgActive Control1 Intervention

Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.

Group V: Semaglutide 2.4 mgActive Control1 Intervention

Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.

Group VI: Placebo 2.4 mg/2.4 mgPlacebo Group2 Interventions

Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Group VII: Placebo 1.0 mg/1.0 mgPlacebo Group2 Interventions

Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 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

0 / 3Eligibility 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

GLP-1 receptor agonists, such as semaglutide, enhance glucose-dependent insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety, aiding in blood sugar control and weight loss. Amylin analogs, like cagrilintide, complement these effects by also slowing gastric emptying, suppressing postprandial glucagon secretion, and increasing satiety. These mechanisms are crucial for Type 2 Diabetes patients as they address both hyperglycemia and obesity, common comorbidities in these patients.

Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes.What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.