Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novo Nordisk A/S
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
What data supports the idea that CagriSema for Type 2 Diabetes is an effective drug?The available research shows that combining semaglutide with cagrilintide (CagriSema) has weight-loss benefits for people with type 2 diabetes. While the specific impact on blood sugar levels is not detailed, semaglutide alone has been shown to effectively lower blood sugar and body weight. Compared to other treatments, oral semaglutide provides better control of blood sugar and helps reduce body weight, even in patients with more advanced diabetes. This suggests that CagriSema could be an effective option for managing type 2 diabetes.12679
Is the drug Cagrilintide, Semaglutide a promising treatment for Type 2 Diabetes?Yes, Cagrilintide, Semaglutide is a promising treatment for Type 2 Diabetes. It helps lower blood sugar levels and body weight, which are important for managing the disease. It is available in both injectable and oral forms, making it convenient for different patient needs. Clinical trials have shown it to be effective and safe, offering better glucose control and weight loss compared to other treatments.12346
What safety data is available for CagriSema in treating Type 2 Diabetes?The safety data for CagriSema, which includes semaglutide, shows that it is generally well-tolerated with a safety profile similar to other GLP-1 receptor agonists. Clinical trials, such as the PIONEER and SUSTAIN programs, have evaluated semaglutide's safety, focusing on cardiovascular safety, gastrointestinal side effects, and other potential risks like hypoglycemia, pancreatic and thyroid cancer, gallbladder events, and diabetic retinopathy complications. Most adverse effects are mild to moderate and transient, with no unexpected safety issues reported. The overall risk/benefit profile is favorable for patients with Type 2 Diabetes.24568
Do I have to stop taking my current medications for the trial?Yes, you must stop taking any medication for diabetes or obesity 90 days before screening, except for short-term insulin treatment for up to 14 days or insulin for gestational diabetes.
Eligibility Criteria
This trial is for people with type 2 diabetes who manage their condition through diet and exercise. Participants will be involved in the study for about a year, receiving either the investigational medicine CagriSema or a placebo.Treatment Details
The study tests how well CagriSema, an experimental medication not yet available by prescription, lowers blood sugar and body weight compared to a placebo—a treatment with no active effect on the body.
4Treatment groups
Active Control
Placebo Group
Group I: CagriSema Dose 2Active Control2 Interventions
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
Group II: Cagrisema Dose 1Active Control2 Interventions
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
Group III: Placebo Dose 2Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks.
Group IV: Placebo Dose 1Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Headlands Research OrlandoOrlando, FL
Southgate Medical Group, LLPWest Seneca, NY
Elligo Clin Res CentreAustin, TX
Headlands Research BrownsvilleBrownsville, TX
More Trial Locations
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
References
Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. [2022]Despite a broad range of pharmacological options for the treatment of type 2 diabetes, optimum glycaemic control remains challenging for many patients and new therapies are necessary. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue in phase 3 development for type 2 diabetes. We assessed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone.
Semaglutide: First Global Approval. [2019]Novo Nordisk has developed a subcutaneous formulation of semaglutide (Ozempic®), a modified human glucagon-like peptide-1 (GLP-1) analogue, for the treatment of type 2 diabetes mellitus. It has been developed using Novo Nordisk's proprietary protein-acylation technology, and is administered using an injection device. Semaglutide lowers blood glucose by stimulating the release of insulin and also lowers body weight. Once-weekly subcutaneous semaglutide has recently been approved in the US, Puerto Rico and Canada, and has received a positive opinion in the EU for the treatment of patients with type 2 diabetes. It will be launched as the Ozempic® Pen, a pre-filled device. Semaglutide is also under regulatory review in Japan and Switzerland for the treatment of type 2 diabetes. Clinical development for obesity, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease is underway worldwide. This article summarizes the milestones in the development of semaglutide leading to this first approval for type 2 diabetes.
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]Semaglutide (Ozempic®) is a new once-weekly agonist of glucagon-like peptide-1 receptors (GLP-1 AR) indicated in the treatment of type 2 diabetes (T2D). Phase III clinical trials of the SUSTAIN programme demonstrated both the efficacy and safety of semaglutide in patients with T2D treated by diet and exercise, oral antidiabetic agents or even insulin. Direct and indirect comparative clinical trials showed that semaglutide (subcutaneous 0.5 or 1.0 mg once weekly) exerts a better glucose-lowering activity and a greater weight loss than other GLP-1 AR. Presented as prefilled pens for subcutaneous injection, semaglutide is currently reimbursed in Belgium after failure of antidiabetic therapy including metformin (HbA1c superior to 7,5 % or 58 mmol/mol) in T2D patients with body mass index ? 30 kg/m².
Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]Semaglutide is an oral glucagon-like peptide receptor agonist approved in 2019 by the U.S. Food and Drug Administration. It is marketed under the brand name Rybelsus and was approved to be used in conjunction with lifestyle modifications to treat individuals with type 2 diabetes. It is the first in its drug class to be administered in a once-daily oral form. Through its actions on glucose control and body weight, this once-daily oral medication could contribute to better glycemic control and healthier lives for many women with type 2 diabetes.
Safety of Semaglutide. [2023]The glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide is the most recently approved agent of this drug class, and the only GLP-1RA currently available as both subcutaneous and oral formulation. While GLP-1RAs effectively improve glycemic control and cause weight loss, potential safety concerns have arisen over the years. For semaglutide, such concerns have been addressed in the extensive phase 3 registration trials including cardiovascular outcome trials for both subcutaneous (SUSTAIN: Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) and oral (PIONEER: Peptide InnOvatioN for the Early diabEtes tReatment) semaglutide and are being studied in further trials and registries, including real world data studies. In the current review we discuss the occurrence of adverse events associated with semaglutide focusing on hypoglycemia, gastrointestinal side effects, pancreatic safety (pancreatitis and pancreatic cancer), thyroid cancer, gallbladder events, cardiovascular aspects, acute kidney injury, diabetic retinopathy (DRP) complications and injection-site and allergic reactions and where available, we highlight potential underlying mechanisms. Furthermore, we discuss whether effects are specific for semaglutide or a class effect. We conclude that semaglutide induces mostly mild-to-moderate and transient gastrointestinal disturbances and increases the risk of biliary disease (cholelithiasis). No unexpected safety issues have arisen to date, and the established safety profile for semaglutide is similar to that of other GLP-1RAs where definitive conclusions for pancreatic and thyroid cancer cannot be drawn at this point due to low incidence of these conditions. Due to its potent glucose-lowering effect, patients at risk for deterioration of existing DRP should be carefully monitored if treated with semaglutide, particularly if also treated with insulin. Given the beneficial metabolic and cardiovascular actions of semaglutide, and the low risk for severe adverse events, semaglutide has an overall favorable risk/benefit profile for patient with type 2 diabetes.
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]Oral semaglutide (Rybelsus®) is a co-formulation of semaglutide, a glucagon-like peptide-1 (GLP-1 RA) receptor agonist, with an absorption enhancer, sodium N- (8- [2- hydroxybenzoyl] amino) caprylate (SNAC), which facilitates the absorption of semaglutide across the gastric epithelium in a concentration dependent manner. The safety and efficacy of oral semaglutide were assessed in the PIONEER clinical trial programme, which included 9543 patients with type 2 diabetes (T2DM). Across a range of different T2DM patients receiving different background medications, oral semaglutide provides more effective glycaemic control than common oral glucose-lowering therapies, associated with a clinically relevant reduction in body weight, including in patients with more advanced T2DM on insulin treatment. The tolerability profile for oral semaglutide was consistent with the other GLP-1 RAs. Cardiovascular (CV) safety of oral semaglutide was noninferior to placebo in CV high-risk patients. Available in three doses (3, 7 and 14 mg) to be gradually increased, Rybelsus® is currently reimbursed in Belgium after failure of antidiabetic treatment (including metformin; HbA1C superior to 7.5 % or 58 mmol/mol) in T2DM patients with a body mass index ? 30 kg/m².
Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. [2022]To evaluate the efficacy and safety of oral semaglutide versus comparators by patient characteristic subgroups in patients with type 2 diabetes.
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. [2023]Semaglutide is a Glucagon-like peptide-1 receptor agonist used in the second-line treatment of poorly controlled type 2 diabetes and can be used in monotherapy or associated with other oral antidiabetics or even insulin, increasing the effectiveness of the treatment. This work aims to analyze the profile of adverse drug reactions reported for semaglutide in Eudravigilance.
Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. [2023]Label="BACKGROUND">Combining the GLP-1 receptor agonist semaglutide with the long-acting amylin analogue cagrilintide has weight-loss benefits; the impact on glycated haemoglobin (HbA1c) is unknown. This trial assessed the efficacy and safety of co-administered semaglutide with cagrilintide (CagriSema) in participants with type 2 diabetes.