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

NCT03799198 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: NN8022-4432U1111-1218-8104
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  Percentage change in body weight from baseline (month 0) to month 12 is presented.

  Month 0, month 12

Secondary Outcomes (15)

• Participants Achieving 5% or More Reduction in Body Weight

  Month 12

• Participants Achieving 10% or More Reduction in Body Weight

  Month 12

• Number of Shared Medical Appointments (SMAs) Attended

  Months 0-12

• Participants Attending 9 or More SMAs

  Months 0-12

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

  Months 0-12

Study Arms (2)

WMP + Rx

EXPERIMENTAL

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.

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

WMP alone

ACTIVE COMPARATOR

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

Other: Weight Management Program (WMP)

Interventions

Weight Management Program (WMP) OTHER

As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic.

WMP + Rx; WMP alone

Medication for chronic weight management (Rx) DRUG

Following listed 5 drugs will be administered as prescribed by the study doctor: 1\) Orlistat (Xenical® pills, per os \[p.o.; by mouth\]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously \[under the skin\]).

WMP + Rx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Pantalone KM, Rogen B, Zirm P, Xiao H, Bena J, Barnard G, Borukh E, Peechakara S, Griebeler ML, Young JB, Burguera B. 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 (EMPOWER-T2D). Diabetes Ther. 2024 May;15(5):1201-1214. doi: 10.1007/s13300-024-01563-0. Epub 2024 Apr 4.

  PMID: 38573466 DERIVED

• Pantalone KM, Smolarz BG, Ramasamy A, Baz Hecht M, Harty BJ, Rogen B, Griebeler ML, Borukh E, Young JB, Burguera B. Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116595. doi: 10.1001/jamanetworkopen.2021.16595.

  PMID: 34255049 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Clinical Transparency and Medical Writing Office (1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: January 7, 2019
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: November 14, 2022
• Results First Posted: June 18, 2021

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)