Clinical trial NCT06780449: A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Official title: Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 400
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 obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.


Eligibility criteria: Inclusion criteria:

* Male or female.
* Age above or equal to 18 years at the time of signing informed consent.
* Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2).

Exclusion criteria:

* Glycated haemoglobin (HbA1c) \>= 6.5 percent (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 week 104
Secondary outcomes:
measure: Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who achieve >= 25 percent body weight reduction
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who achieve >= 30 percent body weight reduction
timeFrame: From baseline (week 0) to week 104
measure: Change in waist circumference
timeFrame: From baseline (week 0) to week 104
measure: Change in waist to height ratio
timeFrame: From baseline (week 0) to week 104
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: Total Cholesterol
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: Triglycerides
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: Free fatty acids
timeFrame: From baseline (week 0) to week 104
measure: Ratio to Baseline in Lipids: Non-HDL cholesterol
timeFrame: From baseline (week 0) to week 104
measure: Change in Body Mass Index (BMI)
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who achieve BMI less than 30 kg/m^2
timeFrame: At week 104
measure: Change in Glycated Haemoglobin (HbA1c) (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in HbA1c (millimoles per mole [mmol/mol])
timeFrame: From baseline (week 0) to week 104
measure: Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
timeFrame: From baseline (week 0) to week 104
measure: Change in FPG (milligrams per deciliter [mg/dL])
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
timeFrame: From baseline (week 0) to week 104
measure: Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
timeFrame: From baseline (week 0) to week 104
measure: Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline
timeFrame: From baseline (week 0) to week 104
measure: Time to T2D diagnosis as per ADA guideline
timeFrame: From baseline (week 0) to week 104
measure: Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score
timeFrame: From baseline (week 0) to week 104
measure: Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)
timeFrame: From baseline (week 0) to week 104
measure: Ratio to baseline in C-reactive protein (CRP)
timeFrame: From baseline (week 0) to week 104
measure: Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])
timeFrame: From baseline (week 0) to week 104
measure: Change in total fat mass by DXA relative to total body mass (kg)
timeFrame: From baseline (week 0) to week 104
measure: Change in total fat mass by DXA absolute to total body mass (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in total fat mass by DXA relative to total body mass (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)
timeFrame: From baseline (week 0) to week 104
measure: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)
timeFrame: From baseline (week 0) to week 104
measure: Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in lean body mass by DXA absolute to total body mass (kg)
timeFrame: From baseline (week 0) to week 104
measure: Change in lean body mass by DXA relative to total body mass (kg)
timeFrame: From baseline (week 0) to week 104
measure: Change in lean body mass by DXA absolute to total body mass (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in lean body mass by DXA relative to total body mass (percentage points)
timeFrame: From baseline (week 0) to week 104
measure: Change in Short Form (SF)-36 Physical functioning score
timeFrame: From baseline (week 0) to week 104
measure: Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT): Physical Function Score
timeFrame: From baseline (week 0) to week 104
measure: Change in IWQOL-Lite-CT: Physical Score
timeFrame: From baseline (week 0) to week 104
measure: Change in IWQOL-Lite-CT: Psychosocial score
timeFrame: From baseline (week 0) to week 104
measure: Change in IWQOL-Lite-CT: Total score
timeFrame: From baseline (week 0) to week 104
measure: Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score
timeFrame: From baseline (week 0) to week 104
measure: Change in Control of Eating questionnaire (CoEQ): Craving Control score
timeFrame: From baseline (week 0) to week 104
measure: Change in CoEQ: Positive Mood score
timeFrame: From baseline (week 0) to week 104
measure: Change in CoEQ: Craving for Sweets score
timeFrame: From baseline (week 0) to week 104
measure: Change in CoEQ: Craving for Savoury score
timeFrame: From baseline (week 0) to week 104
measure: Change in CoEQ: Hunger score
timeFrame: From baseline (week 0) to week 104
measure: Change in CoEQ: Satiety score
timeFrame: From baseline (week 0) to week 104
measure: CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to week 104
measure: CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From baseline (week 0) to week 104
measure: CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TEAEs
timeFrame: From week 104 to end of study (week 162)
measure: CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TESAEs
timeFrame: From week 104 to end of study (week 162)
measure: CagriSema 2.4 mg/2.4 mg: Number of TEAEs
timeFrame: From week 104 to end of study (week 162)
measure: CagriSema 2.4 mg/2.4 mg: Number of TESAEs
timeFrame: From week 104 to end of study (week 162)
Other outcomes:
Locations:
city: Covina
country: United States
facility: Valley Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Honolulu
country: United States
facility: East West Medical Research Institute_Honolulu
state: Hawaii
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group_Bristol
state: Tennessee
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Arlington
country: United States
facility: Washington Cntr Weight Mgmt
state: Virginia
city: Boussu
country: Belgium
facility: CHU Helora - Site Warquignies
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
city: Edegem
country: Belgium
facility: UZA - UZ Antwerpen - Department of Endocrinology
city: Leuven
country: Belgium
facility: UZ Leuven - Endocrinology
city: Victoria
country: Canada
facility: Dr. M.B. Jones Inc
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Premier Clinical Trial Research Network (PCTRN)
state: Ontario
city: Quebec
country: Canada
facility: Alpha Recherche Clinique - Lebourgneuf
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Steno Diabetes Center Aarhus
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus Esbjerg
city: Hellerup
country: Denmark
facility: Center for Klinisk Metabolisk Forskning
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Endokrinologisk forsknings afsnit 159
city: Køge
country: Denmark
facility: Sjællands Universitetshospital
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local De Saude De Matosinhos E.P.E.
state: Matosinhos
city: Lisboa
country: Portugal
facility: APDP - Associação Protectora dos Diabéticos de Portugal
city: Lisboa
country: Portugal
facility: APDP - Associação Protectora dos Diabéticos de Portugal
city: Lisboa
country: Portugal
facility: CUF Descobertas
city: Lisboa
country: Portugal
facility: Hospital Cuf Descobertas S.A.
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao E.P.E
city: Vila Nova de Gaia
country: Portugal
facility: Hospital Luz Arrabida, S.A.
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: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Blizard Institute_Royal London Hospital
city: Swansea
country: United Kingdom
facility: Joint Clinical Research Facility - Swansea
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: