DALLAS — A real-world virtual obesity treatment program that involved use of GLP-1 receptor agonists with intensive lifestyle interventions led to robust and sustained weight loss, according to an analysis of a cohort study.
At 12 months, there was an average weight loss of 16.2% of body weight, with results sustained up to 24 months, reported Donna Ryan, MD, of Pennington Biomedical Research Center in Baton Rouge, Louisiana, during the ObesityWeek annual meeting.
More than two-thirds of participants re-enrolled for a second year. At 2 years, the average weight loss was 17.2%.
Participants also lost an average 6.1 inches in their waist circumstance, with similar reductions in men and women.
“As the program expands, developing a more precise understanding of those who benefit most from these medications and the contribution of the intensive lifestyle intervention to sustain post-medication weight loss will become increasingly important,” Ryan told attendees.
A subset of patients with available data also showed improvements in lipids, HbA1c, liver function tests, insulin, and high-sensitivity C-reactive protein levels. Slightly over half of participants reported improvements in their eating habits, 49.6% increased their exercise, 37.4% improved their sleep, and 29.3% reported improvements in emotional health.
The findings “reinforce how much weight loss we see and that the sustained intervention continues weight loss,” commented Domenica Rubino, MD, of the Washington Center for Weight Management and Research in Arlington, Virginia. “But how ethical is it to treat people with a complex disease, with all of these complications of obesity that we talk about, completely online?”
She acknowledged the expanded access with a completely virtual program, “but on the other hand, we completely trivialize obesity as a disease, and we have it completely focused on weight loss,” she said. “I think we have to be really careful of reducing the treatment of obesity as a disease back to weight loss.”
In an interview after the presentation, Rubino emphasized the seriousness of obesity as a disease with potential complications.
“In the optimal world situation, doctors who are prescribing should evaluate the person from head to toe, do the physical exam, figure out what’s going on, and we have to treat weight, but we also have to treat whatever comorbidities they have for the optimal safety of a person,” Rubino told MedPage Today. “You can have remote sessions, but you can’t just do remote. We have to see the patient, talk with the patient, examine the patient, test the patient, and treat all of their medical conditions.”
The telehealth program, including video visits plus asynchronous check-ins and messaging, uses GLP-1 medications and intensive lifestyle interventions, with one-on-one coaching and digital tracking and medical treatment provided by board-certified physicians. The program costs $1,500 for initial enrollment and currently serves more than 30,000 people in all 50 states and Washington, D.C.
Program criteria includes a body mass index (BMI) greater than 30 or greater than 27 with a weight-related comorbidity, no contraindication to treatment with GLP-1 agonists or an intensive lifestyle intervention, and insurance that covers the medications. Participants must commit to at least 1 year with the program, and Direct-to-Consumer members could opt to renew their membership for a second year with plans starting at $150 per year. Commercial members were automatically enrolled in a 2-year program.
Patients received treatment with semaglutide (Ozempic, Wegovy), liraglutide (Saxenda), dulaglutide (Trulicity), or tirzepatide (Mounjaro), depending on physician judgment, insurance coverage, and medication availability. Some patients also received metformin.
Although the program required insurance coverage for GLP-1 agonists, that requirement was only for 1 month of access, Ryan explained. “Many members included in the cohort did not have continuous medication access given this real-world setting and changes to insurance coverage, as well as challenges with medication availability.”
The dropout rate due to adverse effects from the GLP-1 drugs was 1.75%, and 0.18% of participants experienced severe side effects, including pancreatitis, severe gastrointestinal effects, cholecystectomies, syncope, worsening mood or suicidal ideation, and ketoacidosis.
The intensive lifestyle intervention used a comprehensive, evidence-based curriculum that encouraged incremental changes to diet, sleep, physical activity, and emotional health, which was paired with biweekly accountability coaching meetings during the first year. Members regularly tracked their weight using cellular-connected digital scales and electronically submitted their weight and habit tracking. They completed company questionnaires at baseline and at 6 and 12 months for changes in diet, sleep, exercise, and emotional health.
Members also received additional support and content from online community and events. Participants who continued past the first year could use monthly coaching sessions or participate only in the community without one-on-one coaching.
The researchers analyzed metrics for all 12,821 participants who remained in the program for at least 12 months, plus those who continued to 24 months. Most of the participants (87.1%) were women, average age was 47, and average baseline BMI was 36.7. One in five participants (22.8%) had prediabetes, and 3.9% had type 2 diabetes. Most participants (82.5%) were white; 6.2% were Black, 3.9% were Latinx, and 2.8% were Asian.
Members had an average 7 months of refills and used an average 1.63 GLP-1 agonists, since many members used more than one type. The most commonly used medication was semaglutide (71.4% Ozempic, 40.3% Wegovy); 28.4% used tirzepatide at some point in the 12 months, followed by dulaglutide (8.2%) and liraglutide (6.3%).
The research was funded by Calibrate, the company in the study.
Ryan is an advisor for Calibrate, Wonder Health, Real Appeal, Novo Nordisk, Lilly, Amgen, Altimmune, Biohaven, Carmot Therapeutics, CinRx Pharma, Epitomee, Gila Therapeutics, Scientific Intake, Structure Therapeutics, Xeno Bioscience, and Zealand Pharma. She holds stock options with Calibrate, Epitomee, Scientific Intake, and Xeno Bioscience; is a speaker for Novo Nordisk and Lilly; serves on a data monitoring committee for Lilly; and has a research administration relationship with Novo Nordisk.
Rubino is a speaker for Novo Nordisk and will be a speaker for Lilly. She is an advisor and consultant for Novo Nordisk, Boehringer Ingelheim, and Lilly, and a shareholder in Lilly.
Source Reference: Ryan DH “Metabolic health and weight loss outcomes from a combined GLP-1 medication and ILI program at scale” ObesityWeek 2023.