Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
114 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for people with obesity or overweight who can't tolerate certain diabetes medications. Participants will receive either Cagrilintide or a placebo for about 8 months.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have had problems with GLP-1 medications due to gastrointestinal effects.
I cannot restart GLP-1 medications based on my medical history.
I have a body mass index (BMI) of 30 or higher.
You may not be able to join if
I am pregnant, breastfeeding, or planning to become pregnant.
I have used GLP-1 medications in the last 8 weeks.
I have a history of type 1 or type 2 diabetes.
My blood test shows a glycated hemoglobin (HbA1c) of 6.5% or more.
I have taken glucose-lowering medicines for diabetes or pre-diabetes in the last 90 days.
I have used weight management medications in the last 8 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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City
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Eligibility Criteria
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-i…
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
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