JPRN-jRCT2031220672RecruitingPhase 3
The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease(NN9838-4942) - REDEFINE 3
Ryoma Akihito Hirose0 sites75 target enrollmentStarted: March 2, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 55age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Male or female
- •-Age above or equal to 55 years at the time of signing informed consent.
- •-Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per meter square
- •-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) < 0.85 at rest
- •b.Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (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) more than 180 days before screening
- •-HbA1c 7%-10% (53-86 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, alpfa-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
- •-Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- •- Renal impairment with estimated glomerular filtration rate (eGFR)< 30 mL/min/1.73 m2, as measured by the central laboratory at screening
- •- 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
Investigators
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