A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

NCTNCT06388187Other idNN9838-7749Other idU1111-1298-3451Other id2023-509273-24Other id2023

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 300 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 5 countries
United States, Canada, France, Germany, United Kingdom
Start: 24 Jun 2024
Primary completion: 22 Apr 2026
Completion: 22 Apr 2026
First posted: 29 Apr 2024
Last update posted: 5 May 2026
Conditions: Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 3
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
NCT06388187
24 Jun 2024 to 22 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

Interventions

CagrilintideDrug
SemaglutideDrug
PlaceboDrug

Arms4

Experimental
CagriSema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.
Placebo comparator
Placebo Dose 1
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.
Active comparator
CagriSema Dose 2
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
Placebo comparator
Placebo Dose 2
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in percentage (%).
Achievement of ≥5% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant.

Secondary outcomes(13)

Achievement of ≥10% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant.
Achievement of ≥15% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant.
Achievement of ≥20% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured as count of participant.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in centimeter (cm).
Change in systolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in millimeters of mercury.
Ratio to baseline in lipids: Total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Free fatty acids
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Number of treatment emergent adverse events (TEAEs)
Time frame · From baseline (week 0) to end of study (week 74)
Registry description
Measured as count of events.
Number of treatment emergent serious adverse events (TESAEs)
Time frame · From baseline (week 0) to end of study (week 74)
Registry description
Measured as count of events.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female * Age above or equal to 18 years at the time of signing informed consent 1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m\^2) or 2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes

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