This study has been transitioned to CTIS with ID 2023-506924-94-00 check the CTIS register for the current data. Primary: to confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to first occurrence of MACE (a composite endpoint consisting of CV death,
non-fatal myocardial infarction and non-fatal stroke) from baseline (week 0) to
end of study (up to 242 weeks or more).
Secondary outcome
Time to first occurrence of MACE (a composite endpoint consisting of CV death,
non-fatal myocardial infarction and non-fatal stroke) from baseline (week 0) to
end of study (up to 242 weeks or more).
Background summary
Cagrilintide is a new active substance and considered a *first in class*
medicinal product in the EU, therefore, a dedicated CV outcome study to
evaluate the CV safety profile is required by the EMA. The study has been
designed to address requirements contained in the EMA reflection paper for
evaluation of the CV safety profile of new medicinal products that are intended
for long-term treatment of certain CV and metabolic diseases.
The primary purpose of this study is to investigate the long-term CV safety of
CagriSema as fixed dose combination of cagrilintide and semaglutide in
participants with established CVD. Secondly, the study will investigate the
efficacy of CagriSema on CV risk reduction.
Study objective
This study has been transitioned to CTIS with ID 2023-506924-94-00 check the CTIS register for the current data.
Primary: to confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo
with respect to time to first major adverse cardiovascular event (MACE).
Secondary: to confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo
with respect to time to first MACE.
Study design
The study consists of a screening period to assess the participant*s
eligibility, an up to 235-week treatment period (including a 16-week dose
escalation period) and a 7-week follow-up period. The total study duration for
each participant will be up to approximately 245 weeks (up to 3 weeks
screening, up to 235 weeks treatment and 7 weeks follow-up). The study is event
driven; therefore, end of study will be scheduled according to projected study
closure. Study duration is expected to be up to approximately 4.5 years
following randomisation of the first participant.
Intervention
Participants will be randomised 1:1 to once weekly subcutaneous injection of
CagriSema 2.4 mg/2.4 mg, or placebo.
The DV3384 pen-injector is a dual chamber single-dose device. The DV3384
pen-injector administers the two products as a single dose.
Study burden and risks
The study population will consist of participants with established CVD, BMI >=25
kg/m2, with or without T2D and/or CKD. Assessment and treatment of the
participants' CV risk factors and appropriate attention to the standard of care
treatment will be provided throughout the study. Taking into account the
measures taken to minimise risk and burden to participants in this study, the
potential risks identified in association with CagriSema are justified by the
anticipated benefits that may be afforded to participants with established CVD
with or without comorbidities such as obesity, overweight, T2D and CKD.
Flemingweg 8
Alphen aan den Rijn 2408AV
NL
Flemingweg 8
Alphen aan den Rijn 2408AV
NL
Listed location countries
Age
Inclusion criteria
- Male or female
- Age above or equal to 55 years at the time of signing informed consent.
- Body mass index (BMI) above or equal 25.0 kg/m2
- Established CVD as evidenced by at least one of the following:
Prior myocardial infarction
Prior stroke (ischemic or haemorrhagic stroke)
- Symptomatic peripheral arterial disease (PAD) defined as at least one of the
following:
a. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at
rest
b. Intermittent claudication with a above or equal 50% stenosis in a lower
extremity peripheral artery documented by X-ray angiography, MR angiography, CT
angiography or Doppler ultrasound
c. Prior revascularization procedure of a lower extremity peripheral artery
d. Lower extremity amputation at or above ankle due to atherosclerotic disease
(excluding e.g., trauma or osteomyelitis)
For participants with T2D at screening the following inclusion criteria also
apply:
- Diagnosed with type 2 diabetes mellitus (T2D) above or equal to 180 days
before screening
- HbA1c 6.5%-10% (48-86 mmol/mol) (both inclusive), as measured by central
laboratory at screening.
- Treatment with either:
a. Lifestyle intervention alone
b. 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase
inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i),
DPP4-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent
or in combination) according to local label
c. Basal insulin alone or in combination with up to two marketed OADs (refer to
b. above), all according to local label
Exclusion criteria
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris
or transient ischaemic attack within 60 days before screening
- Planned coronary, carotid or peripheral artery revascularisation known on the
day of screening
- Heart failure classified as being in New York Heart Association (NYHA) Class
IV at screening
- Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90
days before screening
- End stage renal disease defined as eGFR below 15 mL/min/1.73 m^2, as measured
by the central laboratory at screening
- Chronic or intermittent haemodialysis or peritoneal dialysis
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-506924-94-00 |
| EudraCT | EUCTR2021-005855-35-NL |
| CCMO | NL82617.056.22 |
| Other | UTN: U1111-1270-0943 |