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Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

Recruiting
18 years and older
All
Phase 1

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Overview

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Eligibility

Key Inclusion Criteria:

  • Male or female (sex at birth)
  • Age 18 years or above at the time of signing the informed consent
  • History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation
  • Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement
  • Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2)

Key Exclusion Criteria:

  • Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
  • Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening
  • History of type 1 or type 2 diabetes
  • Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening
  • Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening
  • Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening

Study details
    Obesity
    Overweight

NCT07607587

Novo Nordisk A/S

27 June 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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