OverweightSCORENCT06874751

Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World

An observational study of Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Overweight, Obesity, Atherosclerotic Cardiovascular Disease (ASCVD)
What is being tested?: No treatment given
How many people: 45,456 participants
Where: 1 siteUnited States
Study dates: 6 Dec 2024to 28 Mar 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
Adult, Older adult

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).

Who may be able to join

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
Participants with established ASCVD defined as a diagnosis of MI, diagnosis of ischemic stroke, and/or evidence of peripheral arterial disease
Participants who are above or equal to (≥) 45 years old by the end of data availability
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
Participant with continuous insurance enrolment eligibility above or equal to (≥)12 months prior to the index date
Participants with re-confirmed overweight/obesity indication during the baseline period

Who cannot join

Participants with a diagnosis of chronic or acute pancreatitis
Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
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)
Pregnancy in female participants
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 (%)
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)
Participants with evidence of bariatric surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536

Other trials in United States

About this study

Conditions: Overweight, Obesity, Atherosclerotic Cardiovascular Disease (ASCVD)
Being tested: No treatment given
Medical subject headings: Overweight, Obesity, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No treatment givenOther
No treatment given
No treatment givenOther
No treatment given

Study groups in NCT06874751
Study group	Role	What they receive
Cohort: Semaglutide Users		Participants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users). Receives: Other: No treatment given
Cohort: Semaglutide Non-users		Participants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who are semaglutide 2.4 mg non-users. Receives: Other: No treatment given

What is being measured

The primary outcome is the main question the study is designed to answer.

Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)
Measured as months
Occurrence of any of the following individual component events:
1. Myocardial Infarction (MI)
2. Stroke
3. Hospitalization for Heart Failure (HF)
4. Coronary revascularization
5. All-cause mortality The event date will be the earliest occurrence of one of the individual components.
Measured: Index date, earliest of revised MACE-5 and end of follow-up, up to 30 months
Revised 3-Point Major Adverse Cardiovascular Events (MACE-3) (time-to-event)
Measured as months
Occurrence of any of the following individual component events:
1. MI
2. Stroke
3. All-cause mortality The event date will be the earliest occurrence of one of the individual components.
Measured: Index date, earliest of revised MACE-3 and end of follow-up, up to 30 months

Secondary outcomes (8)

MI (time-to-event)
Measured as months
Participants who were diagnosed of MI (identified using International Classification of Disease, 10th Edition, Clinical Modification [ICD-10-CM] diagnosis codes) observed during an inpatient (IP) visit. The event date will be admission date of the IP visit.
Measured: Index date, earliest of MI and end of follow-up, up to 30 months
Stroke (time-to-event)
Measured as months
Participants who were diagnosed of stroke, including both ischemic and hemorrhagic, (identified using ICD-10- CM diagnosis codes) which was observed during an IP visit. The event date will be the admission date of the IP visit.
Measured: Index date, earliest of stroke and end of follow-up, up to 30 months
Hospitalization for HF (time-to-event)
Measured as months
Participants who were diagnosed of HF (identified using ICD-10-CM diagnosis codes) observed during an IP visit. The event date will be the first observed admission date of the IP visit.
Measured: Index date, earliest of hospitalization for HF and end of follow up, up to 30 months
Coronary revascularization (time-to-event)
Measured as months
Participants with evidence of coronary revascularization in any claim (identified using ICD-10-PCS, Current Procedural Terminology [CPT], or Healthcare Common Procedure Coding System [HCPCS] procedure codes). The event date will be the first observed date of coronary revascularization.
Measured: Index date, earliest of hospitalization for Coronary revascularization and end of follow up, up to 30 months
All-cause mortality (time-to-event)
Measured as months
Participants with evidence of death as recorded at the month and year level in KRD and defined as a death record observed within the last month of follow-up. The event date will be the earliest of the end of follow-up (e.g., bariatric surgery within the month of death and last month of follow-up) or the last day of the recorded month of death.
Measured: Index date, end of follow up, up to 30 months
MACE-5
Measured as months
Occurrence of any of the following individual component events:
1. MI
2. Stroke
3. Hospitalization for HF
4. Coronary revascularization
5. CV-related mortality The event date will be the earliest occurrence of one of the individual components.
Measured: Index date, earliest of MACE-5 and end of follow-up, up to 30 months
MACE-3
Measured as months
Occurrence of any of the following individual component events:
1. MI
2. Stroke
3. CV-related mortality The event date will be the earliest occurrence of one of the individual components.
Measured: Index date, earliest of MACE-3 and end of follow-up, up to 30 months
CV-related mortality (time-to-event)
Measured as months
Partcipants with any claim within ≤30 days before the date of death (i.e., the last day of the recorded month of death, where death is observed in the last month of follow-up) of the following operational definition to indicate a CV-related mortality (identified using ICD-10-CM diagnosis codes): (1) A primary diagnosis of MI (2) A primary diagnosis of ischemic or hemorrhagic stroke (3) A primary diagnosis of HF (4) Evidence of peripheral arterial revascularization, coronary revascularization, CABG, PCI, or carotid intervention in any claim (identified using ICD-10-PCS, CPT, or HCPCS procedure codes).
(5) A primary diagnosis of CV hemorrhage (excluding hemorrhagic stroke) (6) A primary diagnosis of other CV conditions including unstable angina, sudden cardiac arrest, cardiogenic shock, and other cerebrovascular and CV events.
The event date will be the earliest of the end of follow-up (e.g., bariatric surgery within the month of death) or the date of death.
Measured: Index date, earliest of MACE-3 and end of follow-up, up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 202428 Mar 2025

First posted13 Mar 2025
Study start6 Dec 2024
Primary completion28 Mar 2025
Study completion28 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OverweightStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 45,456 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06874751
Sponsor's protocol ID: NN9536-8515
Other IDs: U1111-1318-9978
Acronym: SCORE
Status last verified: May 2025
First submitted: 8 Mar 2025
Last updated: 21 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Publications

Smolderen KG, Mena-Hurtado C, Zhao Z, Michalak W, Faurby M, Smolarz BG, Kosiborod MN, Song J, Chen Y, Boland J, Nanna MG. Lower risk of cardiovascular events in patients initiated on semaglutide 2.4 mg in the real-world: Results from the SCORE study (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World). Diabetes Obes Metab. 2025 Nov;27(11):6691-6704. doi: 10.1111/dom.70080. Epub 2025 Sep 9.
PubMed 40926360

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overweight trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World
ClinicalTrials.gov ID: NCT06874751
Acronym / sponsor ID: SCORE / NN9536-8515
Conditions: Overweight, Obesity, Atherosclerotic Cardiovascular Disease (ASCVD)
Study type: Observational
Recruitment status: Completed
Enrolment: 45,456 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 6 Dec 2024 (actual)
Primary completion: 28 Mar 2025 (actual)
Study completion: 28 Mar 2025 (actual)
First posted: 13 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Cohort: Semaglutide Users	–	Other: No treatment givenParticipants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who initiated semaglutide 2.4 mg (semaglutide 2.4 mg users).
Cohort: Semaglutide Non-users	–	Other: No treatment givenParticipants age above or equal to (≥) 45 years with overweight or obesity and established ASCVD who are semaglutide 2.4 mg non-users.

Who may qualify

Ages: 45 years and older
Sex: All
Age groups: Adult, Older adult
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).

Key inclusion criteria (6 listed)

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
Participants with established ASCVD defined as a diagnosis of MI, diagnosis of ischemic stroke, and/or evidence of peripheral arterial disease
Participants who are above or equal to (≥) 45 years old by the end of data availability
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
Participant with continuous insurance enrolment eligibility above or equal to (≥)12 months prior to the index date

Key exclusion criteria (7 listed)

Participants with a diagnosis of chronic or acute pancreatitis
Participants with a diagnosis of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
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)
Pregnancy in female participants
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 (%)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No treatment givenNo treatment given	Other	Cohort: Semaglutide Users
No treatment givenNo treatment given	Other	Cohort: Semaglutide Non-users

Primary outcome

Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event)
Time frame: Index date, earliest of revised MACE-5 and end of follow-up, up to 30 months
Measured as months Occurrence of any of the following individual component events: 1. Myocardial Infarction (MI) 2. Stroke 3. Hospitalization for Heart Failure (HF) 4. Coronary revascularization 5. All-cause mortality The event date will be the earliest occurrence of one of the individual components.
Revised 3-Point Major Adverse Cardiovascular Events (MACE-3) (time-to-event)
Time frame: Index date, earliest of revised MACE-3 and end of follow-up, up to 30 months
Measured as months Occurrence of any of the following individual component events: 1. MI 2. Stroke 3. All-cause mortality The event date will be the earliest occurrence of one of the individual components.

8 secondary outcomes

MI (time-to-event)
Time frame: Index date, earliest of MI and end of follow-up, up to 30 months
Stroke (time-to-event)
Time frame: Index date, earliest of stroke and end of follow-up, up to 30 months
Hospitalization for HF (time-to-event)
Time frame: Index date, earliest of hospitalization for HF and end of follow up, up to 30 months
Coronary revascularization (time-to-event)
Time frame: Index date, earliest of hospitalization for Coronary revascularization and end of follow up, up to 30 months
All-cause mortality (time-to-event)
Time frame: Index date, end of follow up, up to 30 months
MACE-5
Time frame: Index date, earliest of MACE-5 and end of follow-up, up to 30 months
MACE-3
Time frame: Index date, earliest of MACE-3 and end of follow-up, up to 30 months
CV-related mortality (time-to-event)
Time frame: Index date, earliest of MACE-3 and end of follow-up, up to 30 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Derived from this study: PubMed 40926360Smolderen KG, Mena-Hurtado C, Zhao Z, Michalak W, Faurby M, Smolarz BG, Kosiborod MN, Song J, Chen Y, Boland J, Nanna MG. Lower risk of cardiovascular events in patients initiated on semaglutide 2.4 mg in the real-world: Results from the SCORE study (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World). Diabetes Obes Metab. 2025 Nov;27(11):6691-6704. doi: 10.1111/dom.70080. Epub 2025 Sep 9.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Related trials for Overweight

RecruitingObservational study
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Transparency (dept. 2834) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revised 5-Point Major Adverse Cardiovascular Events (MACE-5) (time-to-event) (time frame: Index date, earliest of revised MACE-5 and end of follow-up, up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06874751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.