Clinical trial NCT06388187: A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
Official title: Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of ≥5% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
Secondary outcomes:
measure: Achievement of ≥10% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of ≥15% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of ≥20% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Ratio to baseline in lipids: Free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 74)
measure: Number of treatment emergent serious adverse events (TESAEs)
timeFrame: From baseline (week 0) to end of study (week 74)
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Aurora FDRC Inc.
state: California
city: Plantation
country: United States
facility: Clinical Trial Res Assoc,Inc
state: Florida
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Arlington
country: United States
facility: Washington Cntr Weight Mgmt
state: Virginia
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Pierre-Benite
country: France
facility: Hospices Civils de Lyon-Hopital Lyon Sud-1
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Leipzig
country: Germany
facility: AmBeNet GmbH
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Witten
country: Germany
facility: Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann
city: Bradford-on-Avon
country: United Kingdom
facility: The Health Centre
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital_Cambridge
city: Coventry
country: United Kingdom
facility: WISDEM Centre
city: Soham
country: United Kingdom
facility: The Staploe Medical Centre
city: Swansea
country: United Kingdom
facility: Joint Clinical Research Facility - Swansea
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: