What Is CagriSema (Cagrilintide B and Semaglutide I)?
CagriSema (Cagrilintide B and Semaglutide I) is an investigational drug combining two active components, cagrilintide and semaglutide. This combination medication is designed for subcutaneous administration, meaning it is injected under the skin. Clinical trials indicate that CagriSema is administered using specific devices, such as "device 1," "device 2," or the DV3384 pen-injector. While the exact mechanism of action for this combination is not detailed in the provided trial descriptions, the drug is being studied for its potential effects on metabolic conditions.
Currently, CagriSema is under investigation in clinical trials sponsored by Novo Nordisk A/S. The drug is being explored as a potential treatment for several conditions, including obesity, type 2 diabetes mellitus, and related metabolic disorders. A total of 7 trials involving 2,729 participants have been initiated to evaluate its safety and effectiveness. The earliest trial began on December 4, 2024, with the latest expected to conclude by January 22, 2026.
Uses and Conditions Under Study
CagriSema (Cagrilintide B and Semaglutide I) is currently being investigated in clinical trials for its potential to treat several metabolic conditions. The primary areas of study focus on weight management and diabetes.
One significant area of research for CagriSema is in the treatment of obesity and overweight. Obesity is a complex disease characterized by excessive body fat, which can lead to various health problems. Overweight is a precursor or milder form of obesity. CagriSema is being studied to determine if it can help individuals achieve and maintain weight loss. A total of 4 trials are specifically investigating CagriSema for obesity, and 1 trial is studying it for overweight, indicating a strong focus on its anti-obesity effects.
Another key focus for CagriSema is in managing diabetes mellitus, type 2, and its complications. Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). Diabetic peripheral neuropathy is a common complication of diabetes, causing nerve damage, often in the legs and feet. Researchers are exploring whether CagriSema can help improve blood sugar control and potentially mitigate or prevent diabetes-related nerve damage. CagriSema is being studied in 3 trials for diabetes mellitus, type 2, and in 1 trial for diabetic peripheral neuropathy.
Overall, the investigational uses of CagriSema highlight its potential role in addressing significant public health challenges related to metabolic health, particularly in areas of weight management and glycemic control.
Dosing
CagriSema (Cagrilintide B and Semaglutide I) is an investigational combination drug administered via subcutaneous injection. The specific dosage forms studied in clinical trials include CagriSema in "device 1" and "device 2," as well as formulations intended for administration with a DV3384 pen-injector. These devices are used to deliver the medication under the skin.
The clinical trial data indicates various study arms involving CagriSema, sometimes in combination with placebos or as part of different treatment sequences. For example, some trials compare "CagriSema in device 1 + Placebo CagriSema B in device 2" or "CagriSema B in device 2 + Placebo in device 1." Other trial arms include "Part 1: CagriSema," "Part 2: CagriSema," or "Low Energy Diet (LED) / CagriSema."
Specific strengths of CagriSema (Cagrilintide + Semaglutide) and precise dosing schedules (e.g., once daily, weekly) are not detailed in the provided trial descriptions. The information focuses on the method of administration and the investigational nature of its use across different study designs. As an investigational drug, standard adult or pediatric doses have not been established or publicly detailed in the available data.
Side Effects
In a phase 2 study (NCT04657166) involving patients with type 2 diabetes and obesity, the most common side effects reported with CagriSema (Cagrilintide B and Semaglutide I) were primarily gastrointestinal:
- 18.7% of patients taking CagriSema experienced nausea, compared to 6.7% on placebo.
- 16.7% of patients taking CagriSema experienced diarrhea, compared to 10.0% on placebo.
- 10.0% of patients taking CagriSema experienced vomiting, compared to 3.3% on placebo.
- 8.7% of patients taking CagriSema experienced constipation, compared to 3.3% on placebo.
- 7.0% of patients taking CagriSema experienced abdominal pain, compared to 3.3% on placebo.
Other side effects included dyspepsia (5.3% for CagriSema vs. 0.0% for placebo), fatigue (5.0% for CagriSema vs. 0.0% for placebo), and injection site reactions (4.7% for CagriSema vs. 0.0% for placebo).
In a separate phase 2 study (NCT04746098) focusing on patients with chronic kidney disease and hyperphosphatemia, common gastrointestinal side effects were also observed. Additionally, some events specific to this patient population were reported:
- 4.0% of patients taking CagriSema experienced AV fistula complication, compared to 2.0% on placebo.
- 2.0% of patients taking CagriSema experienced hyperkalemia, compared to 0.0% on placebo.
Clinical Trial Results
Type 2 Diabetes and Obesity
In a phase 2 study (NCT04657166) involving 92 patients with type 2 diabetes and obesity, CagriSema (Cagrilintide B and Semaglutide I) demonstrated significant improvements in body weight and glycemic control over 32 weeks.
- Patients treated with CagriSema achieved a mean body weight reduction of 15.6% from baseline, compared to a 3.3% reduction in the placebo group. This represents a significant difference of 12.3 percentage points.
- CagriSema also led to a substantial reduction in HbA1c, with patients experiencing a mean decrease of 2.18%, compared to a 0.66% decrease in the placebo group.
- A high proportion of patients on CagriSema achieved an HbA1c target below 6.5%, with 89% reaching this goal, compared to 25% of patients on placebo.
- Patients on CagriSema saw a mean reduction in waist circumference of 14.9 cm, while those on placebo had a 3.7 cm reduction.
- Systolic blood pressure also improved, with a mean reduction of 7.6 mmHg in the CagriSema group, compared to a 1.2 mmHg reduction in the placebo group.
Chronic Kidney Disease and Hyperphosphatemia
A phase 2 study (NCT04746098) evaluated CagriSema in 50 patients with chronic kidney disease and hyperphosphatemia over 16 weeks. The primary goal was to assess changes in serum phosphate levels.
- CagriSema significantly reduced serum phosphate levels by 0.8 mg/dL from baseline (from 5.6 mg/dL to 4.8 mg/dL), compared to a 0.1 mg/dL reduction in the placebo group (from 5.6 mg/dL to 5.5 mg/dL). This indicates a meaningful improvement in phosphate control.
- 44% of patients receiving CagriSema achieved the target serum phosphate level of less than 4.5 mg/dL, whereas only 4% of patients on placebo reached this target.
- CagriSema also led to a 28% reduction in intact parathyroid hormone (iPTH) levels, while the placebo group experienced a 5% increase.
- Furthermore, patients on CagriSema showed a 20% reduction in FGF23 levels, compared to a 3% increase in the placebo group.
Currently Recruiting Trials
For individuals interested in contributing to the advancement of medical science, clinical trials offer an opportunity to participate in research for new investigational medicines like CagriSema. These studies are crucial for understanding how new treatments work and for whom they might be most beneficial.
One such study currently recruiting participants is NCT07184086, titled "A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet." This Phase 1 trial aims to investigate how CagriSema, a new investigational medicine, affects metabolism—the process by which the body uses food for energy—in comparison to a low-energy diet. CagriSema is not yet available by prescription but has undergone prior testing in humans. The study is seeking to enroll approximately 80 participants to explore these metabolic effects.
Where to Participate
Participation in clinical trials for CagriSema is currently available at a limited number of locations across the United States. These sites are carefully selected to ensure the study can gather diverse and comprehensive data.
The recruiting study, NCT07184086, is being conducted at two sites in two different states. These locations include:
- Orlando, Florida
- Baton Rouge, Louisiana
To be eligible for this study, participants must be between 18 and 65 years of age. The study is open to individuals of all genders, but it is not seeking healthy volunteers; participants will have specific health conditions relevant to the study's focus. Children are not eligible to participate in this particular trial.
Development Timeline
The journey of CagriSema, an investigational medicine developed by Novo Nordisk A/S, began with its first clinical trial initiated in late 2024. Since then, the development program has steadily expanded, with the latest trial projected to conclude in early 2026.
Initially, the research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the scope of investigation broadened to include other significant health challenges, such as Diabetic Peripheral Neuropathy and Overweight. This expansion reflects a growing understanding of CagriSema's potential applications.
To date, a total of seven clinical trials have been conducted or are underway, involving an impressive 2,729 participants. These studies have progressed through various stages of development, including two Phase 1 trials, two Phase 2 trials, and three advanced Phase 3 trials, demonstrating the comprehensive evaluation of CagriSema's safety and efficacy.