Clinical trial NCT06323174: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 180
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 much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 years or above at the time of signing the informed consent
* Diagnosed with type 2 diabetes \>=30 days before screening
* HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
* Body mass index (BMI) \>=23 kilograms per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
* Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m\^2) as determined by central laboratory at screening
* Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
* History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Primary outcomes:
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 40)
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of participants who achieve greater than or equal to (>=) 10% body weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of participants who achieve >=15% body weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])
timeFrame: At end of treatment (week 40)
measure: Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)
timeFrame: At end of treatment (week 40)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of participants who achieve >=5% body weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of participants who achieve >=20% body weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in systolic blood pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in diastolic blood pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in high sensitivity C-reactive protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: Total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: Free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Ratio to baseline in lipids: Non-HDL cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)
timeFrame: At end of study (week 52)
measure: Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in SF-36v2 score: Physical Component Summary score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in SF-36v2 score: Mental Component Summary score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in leptin
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Change in soluble leptin receptor
timeFrame: From baseline (week 0) to end of treatment (week 40)
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of treatment +7 weeks (week 47)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter
timeFrame: From baseline (week 0) to end of treatment +7 weeks (week 47)
measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
timeFrame: From baseline (week 0) to end of treatment + 7 weeks (week 47)
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: Nat Res Inst Huntington Park
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston
state: Florida
city: Newton
country: United States
facility: Alliance for Multispec Res
state: Kansas
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Troy
country: United States
facility: Arcturus HC PLC Troy Med Res
state: Michigan
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Portland
country: United States
facility: Summit Research Network Oregon Inc.
state: Oregon
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Medical Specialists
state: Texas
city: Austin
country: United States
facility: Elligo Clin Res Centre
state: Texas
city: Brownsville
country: United States
facility: Headlands Research Brownsville
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Research of San Antonio
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice PA
state: Texas
city: Weslaco
country: United States
facility: Valley Diab. & Endo Comp Ctr
state: Texas
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital-Endocrinology
state: Beijing
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University-Endocrinology
state: Jiangsu
city: Ji'Nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Debrecen
country: Hungary
facility: Belinus Bt.
state: Hajdu-Bihar Varmegye
city: Nyíregyháza
country: Hungary
facility: Borbánya Praxis E.Ü. Kft.
state: Szabolcs-Szatmar Varmegye
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft.
city: Budapest
country: Hungary
facility: PVN Kutato Kft.
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Catanzaro
country: Italy
facility: Policlinico Mater Domini Università di Catanzaro
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele Milano
city: Roma
country: Italy
facility: Azienda Ospealiero Universitaria Policlinico Umberto I
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk Sp. z o.o.
state: Podkarpackie
city: Bialystok
country: Poland
facility: Osteo-Medic s.c. A. Racewicz, J. Supronik
city: Białystok
country: Poland
facility: Renew Clinic Sp. z o.o.
city: Lodz
country: Poland
facility: Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
city: Warszawa
country: Poland
facility: NBR Polska Tomasz Klodawski
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Zamość
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Al Ahsa
country: Saudi Arabia
facility: King Abdulaziz Hospital-Al Ahsa-National Guard
city: Jeddah
country: Saudi Arabia
facility: National Guard Hospital - Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Riyadh
country: Saudi Arabia
facility: King Khaled University Hospital,King Saud Univ. Med. City
city: Riyadh
country: Saudi Arabia
facility: King Salman Bin Abdulaziz Hospital
city: Belgrade
country: Serbia
facility: CHC Zvezdara, Clinical department for endocrinology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zemun
city: Zajecar
country: Serbia
facility: Policlinic for diabetes
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: