A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

Qualifiers

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/m²), or BMI >= 27.0 kg/m² with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cagrilintide
  • Placebo cagrilintide
  • Placebo semaglutide

Treatment groups

285 Participants
are divided into 3 treatment groups

Sponsors and collaborators