A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
Recruiting
Phase 3Interventional Study
OverweightObesity
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
285 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for adults with excess body weight who want to lose weight. If you join, you may receive either the study medicine cagrilintide or a placebo. The study will last about 9 months.
Are You a Good Fit for This Trial?
You may be able to join if
I can give informed consent before any study activities.
I am 18 years or older.
My body mass index (BMI) is 30 or higher, or 27 or higher with a related health issue.
You may not be able to join if
I have a history of Type 1 Diabetes or Type 2 Diabetes.
I have previously used amylin-based compounds.
I have taken any weight management medications in the past 180 days.
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 a few quick questions to see if you may meet the eligibility requirements.
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development t…
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
Trial Locations
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Eligibility Criteria
Inclusion criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female (sex assigned at birth, inclusive of all gender i…
Inclusion criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18 years or above at the time of signing the informed consent.
* Body mass index (BMI) greater than or equal to (\>=) 30.0 kilograms per square meter (kg/m\^2), or BMI \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
Exclusion criteria:
* History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D).
* Previous dosing of marketed or non-marketed amylin-based compounds.
* Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
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