Corporate Presentation
Obesity
Survodutide
The Phase 3 program with survodutide in obesity,
SYNCHRONIZE™, has been initiated
SYNCHRONIZETM-11
Efficacy and safety in patients
with obesity without T2DM
Inclusion criteria
Study design
•
HbA1c <6.5% (no history of diabetes)
BMI ≥30 or BMI ≥27 with
comorbiditiesa
•
N=600
•
1:1:1 ratio (3.6 mg, 6.0 mg,
or placebo)
SYNCHRONIZETM-22
Efficacy and safety in patients
with obesity and T2DM
HbA1c ≥6.5% and <10%
BMI ≥27
T2DM managed with diet and exercise
alone or with stable pharmacological
treatment
SYNCHRONIZETM-CVOT3
Long-term CV safety in patients
with obesity and established
CVD/CKD or risk factors for CVD
·
BMI ≥27 with CVD and/or at least two
weight-related risk factors for CVD, or
• BMI ≥30 with CVD/CKD and/or at least
two weight-related factors for CVD
• Trial duration: 76 weeks
ZEAL&
ZEALAND PHARMA
Boehringer
Ingelheim
Primary endpoint
•
Percentage change in body weight
from baseline to Week 76
Achievement of body weight reduction
≥5% from baseline to Week 76
•
N=600
•
1:1:1 ratio (3.6 mg, 6.0 mg
or placebo)
•
•
Trial duration: 76 weeks
•
N=4,935
•
1:1:1 ratio (3.6 mg, 6.0 mg
or placebo)
•
Trial duration: up to 114 weeks
Percentage change in body weight
from baseline to Week 76
Achievement of body weight reduction
≥5% from baseline to Week 76
•
Time to first occurrence of any of
five major adverse cardiac events
(5P-MACE) to demonstrate non-
inferiority
aComorbidities comprise dyslipidemia, hypertension, obstructive sleep apnea, and others.
Inclusion criteria for all three trials include age ≥18 years. 5P-MACE includes cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, ischemia-related coronary revascularization or heart failure.
Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights in the Nordic countries).
Sources: 1. SYNCHRONIZE-1. ClinicalTrials.gov (NCT06066515), accessed November 2023; 2. SYNCHRONIZE-2. ClinicalTrials.gov (NCT06066528), accessed November 2023; 3. SYNCHRONIZE-CVOT. ClinicalTrials.gov
(NCT06077864), accessed November 2023.
BMI-body mass index; CKD=chronic kidney disease; CV-cardiovascular; CVD-cardiovascular disease; CVOT=cardiovascular outcomes trial; HbA1c=hemoglobin A1c; T2DM-type 2 diabetes mellitus.
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