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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Medication for chronic weight management (Rx); Other: Weight Management Program (WMP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03799198

NN8022-4432

U1111-1218-8104 (Other Identifier)

Details and patient eligibility

About

Researchers are doing this study to compare the effects of drugs approved for long-term weight loss combined with an employer-based weight management program with the effects of the weight management program without drugs for weight loss. If participants agree to be in this study, they will join the Cleveland Clinic Integrated Medical Weight Management Program (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss. Participants have an equal chance of being in either of the treatment groups. The total study duration for the individual participants will be approximately one year.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

WMP + Rx

Experimental group

Description:

Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg.

Treatment:

Other: Weight Management Program (WMP)

Drug: Medication for chronic weight management (Rx)

WMP alone

Active Comparator group

Description:

Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.

Treatment:

Other: Weight Management Program (WMP)