Clinical trial • Phase III • Endocrinology

CAGRILINTIDE, SEMAGLUTIDE for Obesity

Phase III trial of CAGRILINTIDE, SEMAGLUTIDE for Obesity.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Obesity
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
13-09-2024
First CTIS Authorization Date
16-01-2025

Trial design

Intervention: CagriSema (cagrilintide s.c. 2.4 mg + semaglutide s.c. 2.4 mg) once weekly; Comparator: Placebo + Placebo-controlled, adaptive Phase III trial in Portugal, Denmark, Belgium.

Comparator
Intervention: CagriSema (cagrilintide s.c. 2.4 mg + semaglutide s.c. 2.4 mg) once weekly; Comparator: Placebo + Placebo
Adaptive
True, includes a flexible escalation regime for former placebo group and a dose tapering algorithm mentioned in secondary objectives; specific dose-escalation rules or interim/stopping rules are not provided in the record.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
240

Eligibility

Recruits 240 Vulnerable population not selected; participants must be ≥18 years and provide written informed consent. No assent procedures or special vulnerable-population consent arrangements are specified in the record..

Vulnerable Population
Vulnerable population not selected; participants must be ≥18 years and provide written informed consent. No assent procedures or special vulnerable-population consent arrangements are specified in the record.

Inclusion criteria

  • {"criterion_text":"- Male or female\n- Age above or equal to 18 years at the time of signed informed consent\n- BMI ≥35.0 kg/m2"}

Exclusion criteria

  • {"criterion_text":"- HbA1c≥6.5% (48 mmol/mol) as measured by the central laboratory at screening\n- History of type 1 or type 2 diabetes"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Relative change in body weight","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Achievement of ≥ 20% body weight reduction (yes/no)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of ≥ 25% body weight reduction (yes/no)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of ≥ 30% body weight reduction (yes/no)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in waist circumference","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in waist to height ratio","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in SBP","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ratio to baseline in: •\tTotal cholesterol •\tHigh density lipoprotein (HDL) cholesterol •\tLow density lipoprotein (LDL) cholesterol •\tVery low-density lipoprotein (VLDL) cholesterol •\tTriglycerides •\tFree fatty acids •\tNon-HDL cholesterol","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in BMI","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of BMI < 30 kg/m2","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in glycated haemoglobin (HbA1c)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in Fasting Plasma Glucose (FPG)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of HbA1c < 5.7% and FPG < 100 mg/dL with prediabetes at baseline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to HbA1c < 5.7% and FPG < 100 mg/dL with prediabetes at baseline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Development of HbA1c ≥ 5.7% or FPG > 100 mg/dL with normoglycemia at baseline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Development of T2D as per ADA guideline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to T2D diagnosis as per ADA guideline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in ACC/AHA 10-year ASCVD risk score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Improvement in ≥ 1 pre existing cardiometabolic ORC (hypertension, prediabetes, or dyslipidaemia)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Ratio to baseline in C-reactive protein (CRP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in total fat mass by dual energy X-ray absorption (DXA) absolute and relative to total body mass","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in visceral fat mass by DXA, relative to baseline and relative to total amount of fat mass in visceral fat mass region","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in lean body mass by DXA absolute and relative to total body mass","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in SF-36 Physical functioning score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in IWQOL-Lite-CT: •\tPhysical function score •\tPhysical score •\tPsychosocial score •\tTotal score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change in Control of Eating questionnaire (CoEQ): •\tCraving Control score •\tPositive Mood score •\tCraving for Sweets score •\tCraving for Savoury score •\tHunger score •\tSatiety score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Treatment Emergent Adverse Events (TEAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Treatment Emergent Serious Adverse Events (TESAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achievement of HbA1c ≥ 6.5% or FPG ≥ 126 mg/dL with prediabetes at baseline","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to HbA1c ≥ 6.5% or FPG ≥ 126 mg/dL with prediabetes at baseline","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
True, APDP Associacao Protectora Dos Diabeticos De Portugal is listed as a trial site (patient organisation/association)
Planned Sample Size
240
Recruitment Window Months
45
Consent Approach
Written informed consent is required from participants (participants must be ≥18 years). Subject information and informed consent form documents are provided for multiple countries and languages (documents present in Portuguese, Danish, English, French, Dutch). Separate participant information/consent documents for male partner and pregnancy are listed.

Geography

Total Number Of Sites
14
Total Number Of Participants
160

Portugal

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
540
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Hospital Cuf Descobertas S.A.
Contact Person Name
Inês Sapinho
Contact Person Email
ines.santos@cuf.pt
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Contact Person Name
Rosa Príncipe
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Contact Person Name
Paula Freitas
Contact Person Email
paula_freitas@sapo.pt
Site Name
APDP Associacao Protectora Dos Diabeticos De Portugal
Contact Person Name
Ana Filipa Lopes
Contact Person Email
ana.lopes@apdp.pt
Site Name
Hospital Da Luz Arrabida S.A.
Contact Person Name
Mariana Monteiro

Denmark

Earliest CTIS Part Ii Submission Date
10-12-2024
Latest Decision Or Authorization Date
01-05-2026
Processing Time Days
507
Number Of Sites
5
Number Of Participants
70

Sites

Site Name
Region Hovedstaden
Contact Person Name
Carsten Dirksen
Contact Person Email
carsten.dirksen@regionh.dk
Site Name
Esbjerg Og Grindsted Sygehus
Contact Person Name
Claus Juhl
Contact Person Email
Claus.Bogh.Juhl@rsyd.dk
Site Name
Gentofte Hospital
Contact Person Name
Asger Lund
Contact Person Email
Asger.Lund.01@regionh.dk
Site Name
Region Midtjylland
Contact Person Name
Jens Bruun
Contact Person Email
jensbruu@rm.dk
Site Name
Region Sjaelland
Contact Person Name
Jesper Krogh
Contact Person Email
jekrog@regionsjaelland.dk

Belgium

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
517
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Antwerp University Hospital
Contact Person Name
Eveline Dirinck
Contact Person Email
eveline.dirinck@uza.be
Site Name
Cliniques Universitaires Saint-Luc
Contact Person Name
Audrey Loumaye
Site Name
UZ Leuven
Contact Person Name
Roman Vangoitsenhoven
Site Name
CHU Helora
Contact Person Name
Ides Colin
Contact Person Email
ides.michel.colin@helora.be

Sponsor

Primary sponsor

Full Name
Novo Nordisk A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
4G Clinical B.V.
Responsibilities
RTSM, RTSM helpdesk
Name
Icon Clinical Research Limited
Name
IQVIA Limited
Responsibilities
Patient Interviews

Third parties

  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translation of diaries and patient material","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Celerion Switzerland AG","duties_or_roles":"special laboratory: PK, biomarkers and antibody analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"RTSM, RTSM helpdesk","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"Special laboratory: Antibody analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Abbott GmbH","duties_or_roles":"BG Meter supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Oracle Danmark ApS","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"eCOA Supplier","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Patient Interviews","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging Supplier (DXA)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
cagrilintide semaglutide
Active Substance
CAGRILINTIDE, SEMAGLUTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
cagrilintide 2.4 mg + semaglutide 2.4 mg once weekly
Frequency
Once weekly
Investigational Product Name
Placebo + Placebo
Modality
Other
Combination Treatment
Yes

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