Health Trials

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

ConditionsOverweightObesity
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cagrilintide

    Drug

    Cagrilintide will be administered subcutaneously.

  • Placebo cagrilintide

    Drug

    Placebo matched to cagrilintide will be administered subcutaneously.

  • Placebo semaglutide

    Drug

    Placebo matched to semaglutide will be administered subcutaneously.

Treatment groups

285 Participants
are divided into 3 treatment groups
Group A: Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2Experimental treatment 3 interventions
Group B: Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1Experimental treatment 3 interventions
Group C: Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Relative change in body weight

Measured as percentage (%).

Time frame
From baseline (week 0) to end of treatment (week 26)

Secondary outcomes

1

Number of Treatment Emergent Adverse Events (TEAEs)

Measured as count of events.

Time frame
From baseline (week 0) to end of study (week 33)
2

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Measured as count of events.

Time frame
From baseline (week 0) to end of study (week 33)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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