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

NCTNCT07357766Other idNN9838-8166Other idU1111-1317-0133Other id2024-520448-41

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: The study is withdrawn due to strategic reasons.

Overview

Status: Withdrawn
Phase: Phase 3
Enrollment: 0 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 14 countries
United States, Bulgaria, Denmark, Greece, Hungary, Malaysia, Poland, Portugal, Romania, Slovakia, South Africa, Switzerland, Taiwan, Thailand
Start: 22 Jun 2026 (estimated)
Primary completion: 29 Nov 2027 (estimated)
Completion: 17 Jan 2028 (estimated)
First posted: 22 Jan 2026
Last update posted: 9 Jul 2026
Conditions: Overweight · Obesity

Timeline

1 trial · 1 stopped early

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

2026202720282029

Ph 3
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
NCT07357766
est. 22 Jun 2026 to est. 17 Jan 2028
Withdrawn
Withdrawn

Registry summary

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

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.

Interventions

CagrisemaDrug
Placebo CagriSemaDrug

Arms3

Experimental
CagriSema B in device 2 + Placebo in device 1
Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
Experimental
CagriSema in device 1 + Placebo in device 2
Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
Placebo comparator
Placebo in device 1 + Placebo in device 2
Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 44)
Registry description
Measured in percentage (%).

Secondary outcomes(2)

Number of TEAEs (treatment emergent adverse events)
Time frame · From baseline (week 0) to end of study (week 51)
Registry description
Measured in count of events.
Number of TESAEs (Treatment emergent serious adverse events)
Time frame · From baseline (week 0) to end of study (week 51)
Registry description
Measured in 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.

A trial that is still running, or that stopped early, may post results later.

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 (sex at birth) * Age 18 years or above at the time of signing the informing consent. * Body Mass Index (BMI) is greater than or equal to (\>= ) 30.0 kilograms per square metre (kg/m\^2) or BMI \>= 27.0 kg/m\^2 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: * Glycosylated 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. * Previous exposure to CagriSema in a clinical study.

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