Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

NCT07424430 | Not Yet Recruiting

• 1 other identifier: SEMA-CKM
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

Conditions

Diabetes (DM); Type 2 Diabetes; Obesity (Disorder)

Keywords

semaglutide; T2D; AHA; HbA1c

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c- 3 Years

  The primary outcome measure is investigating the change in HbA1c from baseline to 3 years (± 90 days) among adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs

  Baseline to 3 Years

Secondary Outcomes (68)

• Change in HbA1c- 1 Year

  Baseline to 1 year

• Change in HbA1c- 2 Years

  Baseline to 2 Years

• Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year

  Baseline to 1 Year

• Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years

  Baseline to 2 Years

• Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years

  Baseline to 3 Years

Other Outcomes (11)

• HbA1c

  Baseline to Endpoint (3 Years)

• Proportion of individuals who achieve HbA1c ≤ 7.0%

  Baseline to Endpoint (3 Years)

• Body Weight

  Baseline to Endpoint (3 Years)

Study Arms (3)

T2D Semaglutide Cohort

Adults with T2D prescribed semaglutide

Drug: Semaglutide (SEMA)

T2D other AHA cohort

Adults with T2D prescribed antihyperglycemic medication beside semaglutide including sulfonylurea, DPP4i, and/or SGLT2i

Obesity Semaglutide Cohort

Adults with obesity, defined as BMI equal or greater than 27 kg/m2, prescribed semaglutide

Drug: Semaglutide (SEMA)

Interventions

Semaglutide (SEMA) DRUG

participants who initiate semaglutide

Obesity Semaglutide Cohort; T2D Semaglutide Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa Chu, PhD

CONTACT

(416) 645-2929; lisa.chu@lmc.ca

giovana Romero, Msc

CONTACT

(416) 645-2929; giovana.romero@lmc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share