Investigating the effects of CagriSema, semaglutide, and cagrilintide on insulin regulation in type 2 diabetes
Effect of CagriSema, Semaglutide and Cagrilintide on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes
This study is testing if a new combination treatment called CagriSema can help people with type 2 diabetes better manage their insulin levels compared to other options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Neuss) |
| Trial ID | NCT06403761 on ClinicalTrials.gov |
What this trial studies
This clinical trial examines how CagriSema, a combination of cagrilintide and semaglutide, influences insulin regulation in individuals with type 2 diabetes. Participants will be randomly assigned to receive either CagriSema, semaglutide, cagrilintide, or a placebo, alongside their current diabetes medication, metformin. The study aims to assess the efficacy of these treatments over a duration of approximately 42 weeks. The goal is to better understand the potential benefits of these investigational medicines in managing type 2 diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a diagnosis of type 2 diabetes for at least 180 days and currently on a stable dose of metformin.
Not a fit: Patients who are not on metformin or those with significant cardiovascular disease or chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved insulin regulation and better management of type 2 diabetes for patients.
How similar studies have performed: Other studies have shown promising results with similar GLP-1 receptor agonist approaches, indicating potential for success in this novel combination treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female. * Aged 18-75 years (both inclusive) at the time of signing informed consent. * Diagnosed with type 2 diabetes greater than or equal to (\>=) 180 days before screening. * Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (\<) 60 milliliter per minute per 1.73 square meter \[ml/min/1.73 m\^2\]). * Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole \[mmol/mol\]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c \>= 7.0 % at screening. * Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 45 ml/min/1.73 m\^2 at screening. * Treatment with any medication for the indication of T2D or weight management other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
Where this trial is running
Neuss
- Profil Institut für Stoffwechselforschung GmbH — Neuss, Germany (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.