DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03799198

CompletedPhase 4Results posted

Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity

Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity - a Pragmatic Randomized Trial

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

200

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, % 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 IDNCT03799198
Org study IDNN8022-4432
Secondary IDU1111-1218-8104World Health Organization (WHO)

Timeline

Milestones

Study start2019-01-07actual
Study first posted2019-01-10actual
Primary completion2020-05-22actual
Study completion2020-05-22actual
Results first posted2021-06-18actual
Last update posted2022-11-14actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study
•Male or female, age more than or equal to 18 years at the time of signing informed consent
•Body mass index (BMI) more than or equal 30 kg/m^2
•Enrolled in Cleveland Clinic Employee Health Plan, and expecting to be covered by the Cleveland Clinic Employee Health Plan for the duration of the study

Exclusion criteria

•Contraindications to all of the medications approved by the FDA for chronic weight management according to the label
•Previous participation in this study. Participation is defined as signed informed consent
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
•Participation in another clinical trial within 30 days before screening
•Treatment with any medication with the intention of weight loss within 90 days before screening
•Previous or current participation in Cleveland Clinic's Integrated Medical Weight Management Program
•History of (or plans during the study period for) bariatric surgery, or use of minimally-invasive weight loss devices (i.e. Intragastric balloons, lap bands) not removed within 1 year prior to screening
•History of type 1 or type 2 diabetes mellitus
•Hemoglobin A1c (HbA1c) more than or equal to 6.5% at screening or within 90 days prior to randomization
•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

Endpoints (32)

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

Patient-reported / QoL
18
Other clinical outcomes
8
Weight & body composition
6

Weight & body composition

6 endpoints
Primary/registry result

Change in Body Weight

Time frame:Month 0, month 12

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percent change of body weight95% CI
Weight Management Program (WMP) + Rx-7.69—
Weight Management Program (WMP)-4.19—
Treatment Difference-3.5095% CI-5.51 – -1.50p<0.001ANCOVA
Primary/protocol endpoint

Change in Body Weight

Time frame:Month 0, month 12

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Participants Achieving 5% or More Reduction in Body Weight

Time frame:Month 12

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Weight Management Program (WMP) + Rx62.5—
Weight Management Program (WMP)44.8—
Secondary/registry result

Participants Achieving 10% or More Reduction in Body Weight

Time frame:Month 12

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Weight Management Program (WMP) + Rx34.7—
Weight Management Program (WMP)22.4—
Secondary/protocol endpoint

Participants Achieving 5% or More Reduction in Body Weight

Time frame:Month 12

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Achieving 10% or More Reduction in Body Weight

Time frame:Month 12

≥10% weight-loss responders

threshold achievement, improvement

Patient-reported / QoL

18 endpoints
Secondary/registry result

Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-0.06—
Weight Management Program (WMP)-0.03—
Secondary/registry result

Change in 'Time Management' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-0.10—
Weight Management Program (WMP)-0.19—
Secondary/registry result

Change in 'Physical Tasks' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-0.09—
Weight Management Program (WMP)-0.05—
Secondary/registry result

Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-0.06—
Weight Management Program (WMP)-0.03—
Secondary/registry result

Change in 'Output Tasks' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx0.07—
Weight Management Program (WMP)0.12—
Secondary/registry result

Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-0.43—
Weight Management Program (WMP)-0.48—
Secondary/registry result

Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-1.88—
Weight Management Program (WMP)-1.94—
Secondary/registry result

Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-1.84—
Weight Management Program (WMP)-1.89—
Secondary/registry result

Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP

Time frame:Month 0, month 12

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Score on a scale95% CI
Weight Management Program (WMP) + Rx-9.95—
Weight Management Program (WMP)-7.20—
Secondary/protocol endpoint

Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Time Management' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Physical Tasks' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Output Tasks' as Measured by WLQ-8

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP

Time frame:Month 0, month 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP

Time frame:Month 0, month 12

change from baseline, improvement

Other clinical outcomes

8 endpoints
Secondary/registry result

Number of Shared Medical Appointments (SMAs) Attended

Time frame:Months 0-12

event count, descriptive

Posted result

GroupValue (mean), SMAs95% CI
Weight Management Program (WMP) + Rx9.7—
Weight Management Program (WMP)7.4—
Secondary/registry result

Participants Attending 9 or More SMAs

Time frame:Months 0-12

threshold achievement, descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Weight Management Program (WMP) + Rx79—
Weight Management Program (WMP)51—
Secondary/registry result/low confidence

Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management

Time frame:Months 0-12

descriptive

Posted result

GroupValue (mean), Proportion of days95% CI
Weight Management Program (WMP) + Rx66.48—
Secondary/registry result

Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days

Time frame:Months 0-12

threshold achievement, descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Weight Management Program (WMP) + Rx43—
Secondary/protocol endpoint

Number of Shared Medical Appointments (SMAs) Attended

Time frame:Months 0-12

descriptive

Secondary/protocol endpoint

Participants Attending 9 or More SMAs

Time frame:Months 0-12

threshold achievement, descriptive

Secondary/protocol endpoint

Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management

Time frame:Months 0-12

descriptive

Secondary/protocol endpoint

Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days

Time frame:Months 0-12

threshold achievement, descriptive

Publications (2)

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 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.