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SEMA-CKM
Not yet recruitingReal-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes
Real-world Canadian Retrospective Study Evaluating Longitudinal SEMAglutide Use on Cardio-Kidney-Metabolic Outcomes
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
400
estimated
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥27•HbA1c ≥6.5%
Primary endpoint
•HbA1c, change
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Study population text
The study populations will include adults with T2D prescribed semaglutide (T2D sema cohort) or other AHA (T2D other AHA cohort) including sulfonylurea, DPP4i, and/or SGLT2i, or adults with obesity, defined as BMI equal or greater 27 kg/m2, prescribed semaglutide (obesity sema cohort), who attend an LMC Diabetes \& Endocrinology clinic
Inclusion criteria
T2D Cohort:
Obesity Cohort:
Exclusion criteria
Endpoints (80)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
29 endpointsChange in body weight- 1 Year
Time frame:Baseline to 1 Year
Body weight, absolute change (kg)
change from baseline, improvement
Change in body weight- 2 Years
Time frame:Baseline to 2 Years
Body weight, absolute change (kg)
change from baseline, improvement
Change in body weight- 3 Years
Time frame:Baseline to 3 Years
Body weight, absolute change (kg)
change from baseline, improvement
Percent body weight loss ≥ 5% - 1 Year
Time frame:Baseline to 1 Year
≥5% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 5% - 2 Years
Time frame:Baseline to 2 Years
≥5% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 5% - 3 Years
Time frame:Baseline to 3 Years
≥5% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 10% - 1 Year
Time frame:Baseline to 1 Year
≥10% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 10% - 2 Years
Time frame:Baseline to 2 Years
≥10% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 10% - 3 Years
Time frame:Baseline to 3 Years
≥10% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 15% - 1 Year
Time frame:Baseline to 1 Year
≥15% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 15%- 2 Years
Time frame:Baseline to 2 Years
≥15% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 15%- 3 Years
Time frame:Baseline to 3 Years
≥15% weight-loss responders
threshold achievement, improvement
Change in BMI- 1 Year
Time frame:Baseline to 1 Year
BMI, change
change from baseline, improvement
Change in BMI- 2 Years
Time frame:Baseline to 2 Years
BMI, change
change from baseline, improvement
Change in BMI- 3 Years
Time frame:Baseline to 3 Years
BMI, change
change from baseline, improvement
Change in Waist Circumference- 1 Year
Time frame:Baseline to 1 Year
Waist circumference, change
change from baseline, improvement
Change in Waist Circumference- 2 Years
Time frame:Baseline to 2 Years
Waist circumference, change
change from baseline, improvement
Change in Waist Circumference- 3 Years
Time frame:Baseline to 3 Years
Waist circumference, change
change from baseline, improvement
Percent body weight loss ≥ 5%
Time frame:Baseline to 1 Year
≥5% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 10%
Time frame:Baseline to 1 Year
≥10% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 15%
Time frame:Baseline to 1 Year
≥15% weight-loss responders
threshold achievement, improvement
Body Weight
Time frame:Baseline to 1 Year
Body weight, absolute change (kg)
change from baseline, improvement
BMI
Time frame:Baseline to 1 Year
BMI, change
change from baseline, improvement
Waist Circumference
Time frame:Baseline to 1 Year
Waist circumference, change
change from baseline, improvement
Body Weight
Time frame:Baseline to Endpoint (3 Years)
Body weight, absolute change (kg)
change from baseline, improvement
Percent body weight loss ≥ 5%
Time frame:Baseline to Endpoint (3 Years)
≥5% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 10%
Time frame:Baseline to Endpoint (3 Years)
≥10% weight-loss responders
threshold achievement, improvement
Percent body weight loss ≥ 15%
Time frame:Baseline to Endpoint (3 Years)
≥15% weight-loss responders
threshold achievement, improvement
BMI
Time frame:Baseline to Endpoint (3 Years)
BMI, change
change from baseline, improvement
Glycemic / diabetes
20 endpointsChange in HbA1c- 3 Years
Time frame:Baseline to 3 Years
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c- 1 Year
Time frame:Baseline to 1 year
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c- 2 Years
Time frame:Baseline to 2 Years
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year
Time frame:Baseline to 1 Year
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years
Time frame:Baseline to 2 Years
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years
Time frame:Baseline to 3 Years
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 1 Year
Time frame:Baseline to 1 Year
change from baseline, improvement
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 2 Years
Time frame:Baseline to 2 Years
change from baseline, improvement
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 3 Years
Time frame:Baseline to 3 Years
change from baseline, improvement
Change in insulin use- 1 Year
Time frame:Baseline to 1 Year
categorical status, improvement
Change in Insulin- 2 Years
Time frame:Baseline to 2 Years
categorical status, improvement
Change in Insulin- 3 Years
Time frame:Baseline to 3 Years
categorical status, improvement
Change in TDD of insulin- 1 Year
Time frame:Baseline to 1 Year
change from baseline, improvement
Change in TDD of insulin- 2 Years
Time frame:Baseline to 2 Years
change from baseline, improvement
Change in TDD of insulin- 3 Years
Time frame:Baseline to 3 Years
change from baseline, improvement
HbA1c
Time frame:Baseline to 1 Year
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percent of new onset pre-diabetes
Time frame:Baseline to 1 Year
threshold achievement, event
Percent of new onset T2D
Time frame:Baseline to 1 Year
T2DM prevention
threshold achievement, event
HbA1c
Time frame:Baseline to Endpoint (3 Years)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of individuals who achieve HbA1c ≤ 7.0%
Time frame:Baseline to Endpoint (3 Years)
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
MASH / liver
5 endpointsChange in ALT- 1 Year
Time frame:Baseline to 1 Year
ALT, change
change from baseline, improvement
LOINC 1742-6
Change in ALT- 2 Years
Time frame:Baseline to 2 Years
ALT, change
change from baseline, improvement
LOINC 1742-6
Change in ALT- 3 Years
Time frame:Baseline to 3 Years
ALT, change
change from baseline, improvement
LOINC 1742-6
ALT
Time frame:Baseline to 1 Year
ALT, change
change from baseline, improvement
LOINC 1742-6
ALT
Time frame:Baseline to Endpoint (3 Years)
ALT, change
change from baseline, improvement
LOINC 1742-6
Renal / kidney
14 endpointsChange in eGFR- 1 Year
Time frame:Baseline to 1 Year
eGFR, change
change from baseline, improvement
LOINC 98979-8
Change in eGFR- 2 Years
Time frame:Baseline to 2 Years
eGFR, change
change from baseline, improvement
LOINC 98979-8
Change in eGFR- 3 Years
Time frame:Baseline to 3 Years
eGFR, change
change from baseline, improvement
LOINC 98979-8
Proportion of individuals with ≥ 50% decline in eGFR- 1 Year
Time frame:Baseline to 1 Year
threshold achievement, event
LOINC 98979-8
Proportion of individuals with ≥ 50% decline in eGFR- 2 Years
Time frame:Baseline to 2 Years
threshold achievement, event
LOINC 98979-8
Proportion of individuals with ≥ 50% decline in eGFR- 3 Years
Time frame:Baseline to 3 Years
threshold achievement, event
LOINC 98979-8
Change in uACR- 1 year
Time frame:Baseline to 1 Year
uACR, change
change from baseline, improvement
LOINC 9318-7
Change in uACR- 2 years
Time frame:Baseline to 2 Years
uACR, change
change from baseline, improvement
LOINC 9318-7
Change in uACR- 3 Years
Time frame:Baseline to 3 Years
uACR, change
change from baseline, improvement
LOINC 9318-7
eGFR
Time frame:Baseline to 1 year
eGFR, change
change from baseline, improvement
LOINC 98979-8
uACR
Time frame:Baseline to 1 Year
uACR, change
ratio, improvement
LOINC 9318-7
eGFR
Time frame:Baseline to Endpoint (3 Years)
eGFR, change
change from baseline, improvement
LOINC 98979-8
Proportion of individuals with ≥ 50% decline in eGFR
Time frame:Baseline to Endpoint (3 Years)
threshold achievement, event
LOINC 98979-8
uACR
Time frame:Baseline to Endpoint (3 Years)
uACR, change
ratio, improvement
LOINC 9318-7
Cardiometabolic biomarkers
8 endpointsChange in Blood Pressure- 1 Year
Time frame:Baseline to 1 Year
change from baseline, improvement
Change in Blood Pressure- 2 Years
Time frame:Baseline to 2 Years
change from baseline, improvement
Change in Blood Pressure- 3 Years
Time frame:Baseline to 3 Years
change from baseline, improvement
Change in Lipids- 1 Year
Time frame:Baseline to 1 Year
change from baseline, improvement
Change in Lipids- 2 Years
Time frame:Baseline to 2 Years
change from baseline, improvement
Change in Lipids- 3 Years
Time frame:Baseline to 3 Years
change from baseline, improvement
Blood Pressure
Time frame:Baseline to 1 Year
change from baseline, improvement
Lipids
Time frame:Baseline to 1 Year
change from baseline, improvement
Other (unclassified)
4 endpointsNumber of non-semaglutide GLP-1-based therapies- 1 Year
Time frame:Baseline to 1 Year
event count, descriptive
Number of non-semaglutide GLP-1-based therapies- 2 Years
Time frame:Baseline to 2 Years
descriptive
Number of non-semaglutide GLP-1-based therapies- 3 Years
Time frame:Baseline to 3 Years
descriptive
Incidence of non-acetylsalicylic acid antiplatelet use
Time frame:Baseline to Endpoint
categorical status, descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Pharmaceuticals (Basel, Switzerland)2026 Apr 7PMID42075839doi:10.3390/ph19040583via pubmed acronym asset candidate
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.