300 Participants Needed

CagriSema for Obesity

Recruiting at 23 trial locations
NN
Overseen ByNovo Nordisk
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug CagriSema for obesity?

Research shows that semaglutide, a component of CagriSema, is effective in causing significant and sustained weight loss in people with obesity. Additionally, cagrilintide, when combined with semaglutide, has shown promising results in further enhancing weight loss, making this combination a potentially effective treatment for obesity.12345

Is CagriSema safe for humans?

Semaglutide, a component of CagriSema, is generally well tolerated in humans, with the most common side effects being temporary stomach issues like nausea. Long-term studies have not raised new safety concerns, but ongoing monitoring is important to fully understand its safety.56789

How is the drug CagriSema unique for treating obesity?

CagriSema combines two drugs, semaglutide and cagrilintide, which work together to reduce appetite and promote weight loss. This combination targets different pathways in the brain to enhance the feeling of fullness, making it a novel approach compared to other treatments that typically focus on a single mechanism.2351011

What is the purpose of this trial?

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

Research Team

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for individuals with excess body weight, commonly referred to as obesity. Participants will be randomly assigned to receive either the experimental medication CagriSema or a placebo (dummy medicine) and will participate in the study for approximately 1½ years.

Inclusion Criteria

I am either male or female.
Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m^2) or BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion Criteria

Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
I have a history of diabetes (type 1 or 2).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly subcutaneous injections of CagriSema or placebo for weight loss, with dose escalation over 8-12 weeks and maintenance for up to 60-68 weeks

68 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

  • CagriSema
Trial Overview The effectiveness of different doses of CagriSema, a new combination drug made up of cagrilintide and semaglutide by Novo Nordisk, is being tested. The goal is to determine how well it helps people lose weight compared to a placebo.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CagriSema Dose 1Experimental Treatment2 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 60 weeks.
Group II: CagriSema Dose 2Active Control2 Interventions
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
Group III: Placebo Dose 2Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.
Group IV: Placebo Dose 1Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Findings from Research

In a 20-week trial with 72 adults, once-weekly subcutaneous semaglutide 2.4 mg significantly reduced appetite and energy intake, leading to a 9.9% reduction in body weight compared to only 0.4% with placebo.
Semaglutide improved participants' control over eating and reduced food cravings without causing delayed gastric emptying, indicating its efficacy in managing obesity without adverse effects on gastric function.
The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity.Friedrichsen, M., Breitschaft, A., Tadayon, S., et al.[2021]
Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.
Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer?Colin, IM., Gérard, KM.[2022]
Cagrilintide, an amylin-analog, is being developed alongside semaglutide, a GLP-1 receptor agonist, to enhance weight loss in individuals with obesity, leveraging their complementary mechanisms to reduce appetite.
Clinical trials have shown that both cagrilintide alone and in combination with semaglutide lead to promising weight loss results, supporting the potential of this combination therapy for effective long-term weight management.
Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity.D'Ascanio, AM., Mullally, JA., Frishman, WH.[2023]

References

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. [2021]
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]
Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity. [2023]
Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. [2023]
Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. [2023]
Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. [2022]
Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. [2020]
Semaglutide 2.4 Mg for the Management of Overweight and Obesity: Systematic Literature Review and Meta-Analysis. [2022]
Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system. [2023]
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]
Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial. [2021]
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