A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

NCTNCT06131437Other idNN9838-7832Other idU1111-1292-4835

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 809 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 27 Nov 2023
Primary completion: 8 Dec 2025
Completion: 9 Jan 2026
First posted: 14 Nov 2023
Last update posted: 6 Feb 2026
Conditions: Obesity

Timeline

1 trial · 1 completed

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

20232024202520262027

Ph 3
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
NCT06131437
27 Nov 2023 to 9 Jan 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 compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Interventions

CagrilintideDrug
SemaglutideDrug
TirzepatideDrug

Arms2

Experimental
CagriSema 2.4 mg/2.4 mg
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks.
Active comparator
Tirzepatide 15 mg
Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage (%).

Secondary outcomes(14)

To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage (%).
Achievement of greater than or equal to (≥) 25% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Count of participants.
Achievement of ≥ 30% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in centimeter (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in millimeter of mercury (mmHg).
Change in diastolic blood pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in mmHg.
Relative change in lipids: Total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage.
Relative change in lipids: High-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage.
Relative change in lipids: Non-HDL cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage.
Relative change in lipids: Low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage.
Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage.
Relative change in lipids: Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 84)
Registry description
Measured in percentage.
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame · From baseline (week 0) to end of study (week 90)
Registry description
Count of events.
Number of Treatment Emergent Serious adverse events (TESAEs)
Time frame · From baseline (week 0) to end of study (week 90)
Registry description
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 18 years or above at the time of signing the informed consent * Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2) 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 mellitus

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