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SEMA-CKM

Not yet recruiting

Real-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

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 ≥27HbA1c ≥6.5%

Primary endpoint

HbA1c, change

Identifiers

Registered as

NCT IDNCT07424430
Org study IDSEMA-CKM

Timeline

Milestones

Study first posted2026-02-20actual
Last update posted2026-02-20actual
Study start2026-03estimated (month precision)
Primary completion2026-04estimated (month precision)
Study completion2026-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

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:

A clinical diagnosis of T2D ≥ 1 year
HbA1c ≥ 6.5% (pre-index date)
Initiated semaglutide or other AHA(s) before January 1st, 2023*
Seen by an LMC endocrinologist in the last 18 months as of the query date
≥ one HbA1c value up to 6 months (+ 90 days) prior to index date
Informed data consent for their medical record data to be used for research purposes

Obesity Cohort:

18 years or older
BMI ≥ 27 kg/m2
HbA1c < 6.5% (pre-index date)
Initiated semaglutide before January 1st, 2023*
Seen by an LMC endocrinologist in the last 18 months as of the query date
≥ one HbA1c value up to 6 months (± 90 days) prior to index date
Informed data consent for their medical record data to be used for research purposes

Exclusion criteria

Clinical diagnosis of type 1 diabetes/latent autoimmune diabetes in adults (LADA)
Clinical diagnosis of T2D (obesity cohort only)
Are pregnant at the time of semaglutide or other AHA initiation or became pregnant during follow-up period
Documented history or family history of medullary thyroid carcinoma
Participation in a research study with an Investigational Product
eGFR < 15 mL/min/1.73m2 at index date
Use of non-semaglutide GLP-1-based medication for more than 6 months after the index date (T2D sema cohort and obesity sema cohort)
Use of other AHA for more than 6 months after the index date within the first year of semaglutide use (T2D sema cohort and obesity sema cohort)

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
Glycemic / diabetes
20
Renal / kidney
14
Cardiometabolic biomarkers
8
MASH / liver
5
Other (unclassified)
4

Weight & body composition

29 endpoints
Secondary/protocol endpoint

Change in body weight- 1 Year

Time frame:Baseline to 1 Year

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight- 2 Years

Time frame:Baseline to 2 Years

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight- 3 Years

Time frame:Baseline to 3 Years

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 5% - 1 Year

Time frame:Baseline to 1 Year

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 5% - 2 Years

Time frame:Baseline to 2 Years

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 5% - 3 Years

Time frame:Baseline to 3 Years

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 10% - 1 Year

Time frame:Baseline to 1 Year

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 10% - 2 Years

Time frame:Baseline to 2 Years

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 10% - 3 Years

Time frame:Baseline to 3 Years

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 15% - 1 Year

Time frame:Baseline to 1 Year

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 15%- 2 Years

Time frame:Baseline to 2 Years

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 15%- 3 Years

Time frame:Baseline to 3 Years

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in BMI- 1 Year

Time frame:Baseline to 1 Year

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI- 2 Years

Time frame:Baseline to 2 Years

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI- 3 Years

Time frame:Baseline to 3 Years

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference- 1 Year

Time frame:Baseline to 1 Year

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference- 2 Years

Time frame:Baseline to 2 Years

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference- 3 Years

Time frame:Baseline to 3 Years

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 5%

Time frame:Baseline to 1 Year

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 10%

Time frame:Baseline to 1 Year

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percent body weight loss ≥ 15%

Time frame:Baseline to 1 Year

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body Weight

Time frame:Baseline to 1 Year

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

BMI

Time frame:Baseline to 1 Year

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist Circumference

Time frame:Baseline to 1 Year

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Body Weight

Time frame:Baseline to Endpoint (3 Years)

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Percent body weight loss ≥ 5%

Time frame:Baseline to Endpoint (3 Years)

≥5% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Percent body weight loss ≥ 10%

Time frame:Baseline to Endpoint (3 Years)

≥10% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Percent body weight loss ≥ 15%

Time frame:Baseline to Endpoint (3 Years)

≥15% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

BMI

Time frame:Baseline to Endpoint (3 Years)

BMI, change

change from baseline, improvement

Glycemic / diabetes

20 endpoints
Primary/protocol endpoint

Change in HbA1c- 3 Years

Time frame:Baseline to 3 Years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c- 1 Year

Time frame:Baseline to 1 year

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c- 2 Years

Time frame:Baseline to 2 Years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 1 Year

Time frame:Baseline to 1 Year

change from baseline, improvement

Secondary/protocol endpoint

Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 2 Years

Time frame:Baseline to 2 Years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 3 Years

Time frame:Baseline to 3 Years

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin use- 1 Year

Time frame:Baseline to 1 Year

categorical status, improvement

Secondary/protocol endpoint/low confidence

Change in Insulin- 2 Years

Time frame:Baseline to 2 Years

categorical status, improvement

Secondary/protocol endpoint

Change in Insulin- 3 Years

Time frame:Baseline to 3 Years

categorical status, improvement

Secondary/protocol endpoint

Change in TDD of insulin- 1 Year

Time frame:Baseline to 1 Year

change from baseline, improvement

Secondary/protocol endpoint

Change in TDD of insulin- 2 Years

Time frame:Baseline to 2 Years

change from baseline, improvement

Secondary/protocol endpoint

Change in TDD of insulin- 3 Years

Time frame:Baseline to 3 Years

change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:Baseline to 1 Year

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percent of new onset pre-diabetes

Time frame:Baseline to 1 Year

threshold achievement, event

Secondary/protocol endpoint

Percent of new onset T2D

Time frame:Baseline to 1 Year

T2DM prevention

threshold achievement, event

Other/protocol endpoint

HbA1c

Time frame:Baseline to Endpoint (3 Years)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Change in ALT- 1 Year

Time frame:Baseline to 1 Year

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in ALT- 2 Years

Time frame:Baseline to 2 Years

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in ALT- 3 Years

Time frame:Baseline to 3 Years

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

ALT

Time frame:Baseline to 1 Year

ALT, change

change from baseline, improvement

LOINC 1742-6

Other/protocol endpoint

ALT

Time frame:Baseline to Endpoint (3 Years)

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

14 endpoints
Secondary/protocol endpoint

Change in eGFR- 1 Year

Time frame:Baseline to 1 Year

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in eGFR- 2 Years

Time frame:Baseline to 2 Years

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in eGFR- 3 Years

Time frame:Baseline to 3 Years

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Proportion of individuals with ≥ 50% decline in eGFR- 1 Year

Time frame:Baseline to 1 Year

threshold achievement, event

LOINC 98979-8

Secondary/protocol endpoint

Proportion of individuals with ≥ 50% decline in eGFR- 2 Years

Time frame:Baseline to 2 Years

threshold achievement, event

LOINC 98979-8

Secondary/protocol endpoint

Proportion of individuals with ≥ 50% decline in eGFR- 3 Years

Time frame:Baseline to 3 Years

threshold achievement, event

LOINC 98979-8

Secondary/protocol endpoint

Change in uACR- 1 year

Time frame:Baseline to 1 Year

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change in uACR- 2 years

Time frame:Baseline to 2 Years

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change in uACR- 3 Years

Time frame:Baseline to 3 Years

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

eGFR

Time frame:Baseline to 1 year

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

uACR

Time frame:Baseline to 1 Year

uACR, change

ratio, improvement

LOINC 9318-7

Other/protocol endpoint

eGFR

Time frame:Baseline to Endpoint (3 Years)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

Proportion of individuals with ≥ 50% decline in eGFR

Time frame:Baseline to Endpoint (3 Years)

threshold achievement, event

LOINC 98979-8

Other/protocol endpoint

uACR

Time frame:Baseline to Endpoint (3 Years)

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

Change in Blood Pressure- 1 Year

Time frame:Baseline to 1 Year

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure- 2 Years

Time frame:Baseline to 2 Years

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure- 3 Years

Time frame:Baseline to 3 Years

change from baseline, improvement

Secondary/protocol endpoint

Change in Lipids- 1 Year

Time frame:Baseline to 1 Year

change from baseline, improvement

Secondary/protocol endpoint

Change in Lipids- 2 Years

Time frame:Baseline to 2 Years

change from baseline, improvement

Secondary/protocol endpoint

Change in Lipids- 3 Years

Time frame:Baseline to 3 Years

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Blood Pressure

Time frame:Baseline to 1 Year

change from baseline, improvement

Secondary/protocol endpoint

Lipids

Time frame:Baseline to 1 Year

change from baseline, improvement

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Number of non-semaglutide GLP-1-based therapies- 1 Year

Time frame:Baseline to 1 Year

event count, descriptive

Secondary/protocol endpoint/low confidence

Number of non-semaglutide GLP-1-based therapies- 2 Years

Time frame:Baseline to 2 Years

descriptive

Secondary/protocol endpoint/low confidence

Number of non-semaglutide GLP-1-based therapies- 3 Years

Time frame:Baseline to 3 Years

descriptive

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.