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

RecruitingPhase 1Ages 18 Years - anyAllNovo Nordisk A/S
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ) 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) โ‰ฅ 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
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What it tests

  • Cagrilintide
  • Placebo (matched to Cagrilintide)
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Where

13 sites
Diablo Clinical Research, Inc.
Walnut Creek, United States
Northeast Research Institute
Fleming Island, United States
Jacksonville Ctr For Clin Res
Jacksonville, United States
Center for Diab,Obes & Metab
Pembroke Pines, United States
Encore Medical Research of Weston
Weston, United States
Hope Clin Res & Wellness
Conyers, United States
Monroe Biomedical Research, LLC
Monroe, United States
PHC Accelacare
Statesville, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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