#1 Clinical Trials Search in Europe

Cagrilintide

Cagrilintide is an investigational drug being studied for its potential in treating obesity and type 2 diabetes. This article summarizes key information from several clinical trials examining the efficacy and safety of cagrilintide, both alone and in combination with semaglutide (known as CagriSema). These trials are evaluating how cagrilintide affects body weight, blood sugar control, and other health markers in people with obesity and/or type 2 diabetes.

Table of Contents

What is Cagrilintide?

Cagrilintide is a new investigational drug being developed by Novo Nordisk for weight management and treatment of obesity-related conditions[1]. It is also known by the code name NNC0174-0833[2]. As an investigational medicine, cagrilintide is not yet approved for prescription by doctors and is still undergoing clinical trials to evaluate its safety and effectiveness[3].

How Cagrilintide Works

Cagrilintide is a long-acting drug that resembles one of the body’s own hormones called amylin. Amylin is involved in regulating food intake and body weight[1]. By mimicking the effects of amylin, cagrilintide may help reduce appetite and promote weight loss in people with obesity or overweight.

Conditions Treated with Cagrilintide

Cagrilintide is being studied for the treatment of several conditions related to excess body weight:

  • Obesity and overweight: The primary focus of cagrilintide research is on helping people with excess body weight lose weight and manage obesity[3].
  • Type 2 diabetes: Cagrilintide is being investigated for its potential to help manage blood sugar levels in people with type 2 diabetes who are also overweight or obese[4].
  • Chronic kidney disease: Researchers are studying if cagrilintide can help reduce kidney damage in people with chronic kidney disease, type 2 diabetes, and obesity[5].

CagriSema: Combination with Semaglutide

Many of the clinical trials are studying a combination of cagrilintide with another drug called semaglutide. This combination is referred to as “CagriSema”[3]. Semaglutide is an already approved medication for weight management and type 2 diabetes. Researchers are investigating if the combination of these two drugs (CagriSema) may be more effective than either drug alone for weight loss and managing related health conditions.

How Cagrilintide is Administered

Cagrilintide is given as a subcutaneous injection, which means it is injected under the skin. In clinical trials, it is typically administered:

  • Once a week
  • Using a thin needle
  • In areas such as the stomach, thighs, or upper arms[3]

The dosage of cagrilintide may be gradually increased over time to reach the target dose, which is often 2.4 mg in many of the studies[3].

Ongoing Clinical Trials

Cagrilintide is currently being studied in several clinical trials to evaluate its effectiveness and safety. These trials are investigating various aspects of the drug, including:

  • How it affects body weight in people with obesity or overweight[3]
  • Its impact on blood sugar control in people with type 2 diabetes[4]
  • How it may help protect kidney function in people with chronic kidney disease[5]
  • Its effects on heart rhythm and other safety considerations[2]
  • How the body processes and eliminates the drug[1]

Potential Benefits of Cagrilintide

Based on the ongoing clinical trials, researchers are investigating if cagrilintide may provide the following benefits:

  • Weight loss: Significant reduction in body weight for people with obesity or overweight[3]
  • Improved blood sugar control: Better management of blood glucose levels in people with type 2 diabetes[4]
  • Reduced waist circumference: Decrease in abdominal fat, which is associated with various health risks[6]
  • Improved kidney function: Potential reduction in kidney damage for people with chronic kidney disease[5]
  • Better quality of life: Improvements in physical functioning and overall well-being related to weight loss[6]

Possible Side Effects

As cagrilintide is still in clinical trials, the full range of potential side effects is not yet known. Researchers are carefully monitoring for any adverse events during the studies. Some areas of focus include:

  • Effects on heart rhythm[2]
  • Risk of hypoglycemia (low blood sugar), especially in people with diabetes[4]
  • Any other unexpected side effects that may occur during treatment

It’s important to note that as an investigational drug, cagrilintide is only available to participants in clinical trials at this time. Patients interested in this treatment should discuss with their healthcare provider about potential eligibility for ongoing or future clinical studies.

Aspect Details
Drug Cagrilintide (alone and in combination with semaglutide as CagriSema)
Main Indications Obesity, Type 2 Diabetes
Administration Weekly subcutaneous injection
Key Outcomes Measured Body weight change, HbA1c levels, waist circumference, blood pressure, quality of life
Trial Durations Typically 6 months to 2 years, with some longer-term extension studies
Comparators Placebo, semaglutide alone
Safety Monitoring Adverse events, hypoglycemia episodes, cardiovascular effects
Additional Assessments Lipid profiles, glucose monitoring, body composition (DXA scans)

FAQ

  • What is cagrilintide? Cagrilintide is an investigational drug being developed for weight management and treatment of obesity. It is a long-acting medicine that resembles amylin, a hormone involved in regulating food intake and body weight.
  • How is cagrilintide administered? Cagrilintide is administered as a subcutaneous (under the skin) injection, typically in the stomach, thighs, or upper arms. In most trials, it is given as a weekly injection.
  • What is CagriSema? CagriSema is a combination of two drugs: cagrilintide and semaglutide. It is being studied as a potential treatment for obesity and type 2 diabetes, aiming to provide enhanced weight loss and blood sugar control compared to either drug alone.
  • What are the main outcomes being studied in cagrilintide trials? The main outcomes being studied include changes in body weight, waist circumference, blood sugar levels (HbA1c), blood pressure, and quality of life measures. Researchers are also monitoring safety and side effects.
  • How long do the cagrilintide clinical trials typically last? The duration of cagrilintide trials varies, but many last between 6 months to 2 years. Some studies also include extension phases to evaluate long-term effects and safety.

Ongoing Clinical Trials on Cagrilintide

  • A Study of Cagrilintide and Semaglutide for Weight Loss in People with Type 2 Diabetes and Overweight or Obesity

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Hungary Ireland Poland

  • Study of cagrilintide and semaglutide combination versus placebo in people with type 2 diabetes and painful diabetic peripheral neuropathy

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Norway Spain

  • Study of cagrilintide for weight reduction in adults with overweight or obesity when combined with lifestyle changes

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Norway Poland

  • Study on the Long-term Weight Loss Effects of Cagrilintide and Semaglutide in Adults with Obesity

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Portugal

  • Study on the Effectiveness of NNC0194-0499 and Semaglutide in Treating Non-Alcoholic Steatohepatitis (NASH) in Patients with Fibrosis Stages 2-4

    Not recruiting

    2 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +5

Glossary

  • Cagrilintide: An investigational drug that mimics the hormone amylin, being studied for weight management and obesity treatment.
  • Semaglutide: An approved medication used to treat type 2 diabetes and obesity, often studied in combination with cagrilintide.
  • CagriSema: A combination of cagrilintide and semaglutide being investigated for obesity and type 2 diabetes treatment.
  • Subcutaneous injection: A method of administering medication by injecting it into the layer of tissue beneath the skin.
  • HbA1c: Glycated hemoglobin, a measure of average blood sugar levels over the past 2-3 months.
  • Body Mass Index (BMI): A measure of body fat based on height and weight, used to categorize individuals as underweight, normal weight, overweight, or obese.
  • Waist circumference: A measurement of the distance around the abdomen, used as an indicator of abdominal fat.
  • Placebo: An inactive substance used in clinical trials to compare the effects of a drug against no treatment.
  • Hypoglycemia: Low blood sugar levels, which can be a side effect of some diabetes medications.
  • Lipid profile: A blood test that measures different types of fats in the blood, including cholesterol and triglycerides.
  • Quality of life measures: Assessments used to evaluate how a treatment affects a person's overall well-being and daily functioning.
  • Continuous Glucose Monitoring (CGM): A method to track blood glucose levels throughout the day and night using a small sensor inserted under the skin.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable or unintended sign, symptom, or disease that appears or worsens after starting a medical treatment.

References

  1. https://clinicaltrials.gov/study/NCT05564104
  2. https://clinicaltrials.gov/study/NCT05804162
  3. https://clinicaltrials.gov/study/NCT05567796
  4. https://clinicaltrials.gov/study/NCT05394519
  5. https://clinicaltrials.gov/study/NCT06131372
  6. https://clinicaltrials.gov/study/NCT05996848