Clinical trial NCT06874751: Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World
Official title: Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Atherosclerotic Cardiovascular Disease (ASCVD)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 45456
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants, age above or equal to 45 years with overweight or obesity and established ASCVD will be included in the study. The eligibility date will be defined as the latest of the following dates: first overweight/ obesity ascertainment, first ASCVD diagnosis, and date participant reached age 45. Then, these participants will be divided into those who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users) and those who did not (non-users).

Brief summary: This is a retrospective database study which includes administrative medical and pharmacy claims linked with clinical and laboratory measurements for patients in the US, to evaluate the effectiveness of once-weekly semaglutide 2.4 mg in reducing the risk of CV and other obesity-related clinical outcomes.


Eligibility criteria: Inclusion Criteria:

1. Participants with overweight or obesity defined as at least one overweight/obesity indication of a specified body mass index (BMI) above or equal to (≥) 27.0 kilogram per meter square (kg/m\^2) and undefined obesity/overweight indications, defined by diagnoses and laboratory values
2. Participants with established ASCVD defined as a diagnosis of MI, diagnosis of ischemic stroke, and/or evidence of peripheral arterial disease
3. Participants who are above or equal to (≥) 45 years old by the end of data availability
4. Participants who initiated semaglutide 2.4 mg on or after the eligibility date and June4, 2021 (semaglutide 2.4 mg users) or participants with no evidence of semaglutide 2.4 mg usage (non-users) during January 1, 2016 to December 31, 2023
5. Participant with continuous insurance enrolment eligibility above or equal to (≥)12 months prior to the index date
6. Participants with re-confirmed overweight/obesity indication during the baseline period

Exclusion criteria:

1. Participants with a diagnosis of chronic or acute pancreatitis
2. Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
3. Participants with end-stage kidney disease (ESKD) including chronic or intermittent hemodialysis or peritoneal dialysis, kidney transplant, and/or record of estimate glomerular filtration rate less than (\<) 15 milliliter per minute per 1.73\*meter square (mL/min/1.73m\^2)
4. Pregnancy in female participants
5. Participants with evidence of diabetes including more or equal to (≥)2 diagnoses of type 1 diabetes or more or equal to ( ≥) 2 diagnoses of type 2 diabetes on distinct dates, use of a glucose-lowering agent, and/or glycated hemoglobin (HbA1c) laboratory result above or equal to 6.5 percent (%)
6. Use of a glucagon-like peptide-1 (GLP-1) or GLP-1/gastric inhibitory polypeptide (GIP) receptor ago-nist approved for weight management (excluding semaglutide 2.4 mg)
7. Participants with evidence of bariatric surgery

Primary outcomes:
measure: Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)
timeFrame: Index date, earliest of revised MACE-5 and end of follow-up, up to 30 months
measure: Revised 3-Point Major Adverse Cardiovascular Events (MACE-3) (time-to-event)
timeFrame: Index date, earliest of revised MACE-3 and end of follow-up, up to 30 months
Secondary outcomes:
measure: MI (time-to-event)
timeFrame: Index date, earliest of MI and end of follow-up, up to 30 months
measure: Stroke (time-to-event)
timeFrame: Index date, earliest of stroke and end of follow-up, up to 30 months
measure: Hospitalization for HF (time-to-event)
timeFrame: Index date, earliest of hospitalization for HF and end of follow up, up to 30 months
measure: Coronary revascularization (time-to-event)
timeFrame: Index date, earliest of hospitalization for Coronary revascularization and end of follow up, up to 30 months
measure: All-cause mortality (time-to-event)
timeFrame: Index date, end of follow up, up to 30 months
measure: MACE-5
timeFrame: Index date, earliest of MACE-5 and end of follow-up, up to 30 months
measure: MACE-3
timeFrame: Index date, earliest of MACE-3 and end of follow-up, up to 30 months
measure: CV-related mortality (time-to-event)
timeFrame: Index date, earliest of MACE-3 and end of follow-up, up to 30 months
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: