EMPOWER-T2D

TerminatedPhase 4Results posted

EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial

Lead sponsor

The Cleveland Clinic

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥30•HbA1c ≥7.5%

Primary endpoints

•Body weight, % change•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04531176

Org study ID20-648

Timeline

Milestones

Study first posted2020-08-28actual

Study start2020-09-01actual

Primary completion2022-08-15actual

Study completion2023-08-04actual

Results first posted2024-07-22actual

Last update posted2024-09-19actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Gender: men and women

2. Ethnicity: all ethnic groups

3. Age: ≥18, < 75 years

4. Diagnosis of T2D -A1C within the last 90 days must be >7.5%

5. Obesity, BMI ≥30

6. An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan

Exclusion criteria

1. Type 1 diabetes or known latent autoimmune diabetes of adulthood (LADA)

2. Glomerular Filtration Rate <30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)

3. Current glucocorticoid therapy

4. Currently or within the past 3 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss

5. Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol

6. Mental incapacity or language barrier

7. Pregnancy or plans to become pregnant within the next 2 years

8. Personal or family history of medullary thyroid carcinoma

9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2

10. History of acute pancreatitis, severe liver disease (Cirrhosis), or severe disease of digestive tract

11. History of congestive heart failure

12. History of bariatric or metabolic surgery/procedure

13. Visit with an endocrinologist within the past 1 year

14. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program

Endpoints (4)

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

Glycemic / diabetes

Weight & body composition

2 endpoints

Primary/registry result

Mean Change in Body Weight Between Baseline and 12 Months

Time frame:12 Months

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), % of body weight	95% CI
Obesity-centric Approach + AOM	-8.74	-10.74 – -6.74
Obesity-centric Approach Without AOM	-6.68	-8.71 – -4.65
Usual Care Approach (Comorbidity-centric Approach)	-4.48	-6.52 – -2.45

p0.004t-test, 1 sided

Primary/protocol endpoint

Mean Change in Body Weight Between Baseline and 12 Months

Time frame:12 Months

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/registry result

Mean Change in A1C

Time frame:12 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of glycosylated hemoglobin	95% CI
Obesity-centric Approach + AOM	-2.18	-2.61 – -1.74
Obesity-centric Approach Without AOM	-2.22	-2.65 – -1.79
Usual Care Approach (Comorbidity-centric Approach)	-1.65	-2.09 – -1.22

p0.05t-test, 1 sided

Primary/protocol endpoint

Mean Change in A1C

Time frame:12 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.