January 18, 2023
The Latest in Prescription Therapies for Weight Loss
Obesity levels continue to rise in the U.S., with the CDC last reporting in 2021 that 19.7 percent of children ages two through 19 and 41.9 percent of adults age 20 and older are overweight. Additionally, this data does not take into account what’s been colloquially called the “COVID 15” weight gain that many people reported experiencing during quarantine.
The causes of obesity are complex and include a multitude of factors beyond diet and physical activity levels: genetics, medications, hormones, and social determinants of health are major contributors. Lifestyle changes alone may not be effective in helping some patients get the results they want in achieving a healthy weight.
It’s well known that there’s no safe and effective quick fix for weight loss, nor is there a magic pill. However, recent advances in biotechnology and drug development have led to new therapies that could revolutionize the options for weight management or serve as possible treatments for obesity (when prescribed in combination with diet and exercise changes). Morgan Stanley estimates that obesity drugs may be a “blockbuster pharma category” in the future, and reports that the market for weight management medicines could reach $54 billion over the next ten years. Here is a roundup of our member companies making advances in these medications.
On the Fast Track
Eli Lilly and Company made a major breakthrough last October when the company received fast track designation from the FDA to investigate how its novel treatment for the management of Type 2 diabetes may also have applications in helping obese patients lose weight.
Tirzepatide, also known by its brand name of Mounjaro, was approved by the FDA in May 2022 to manage blood sugar levels in patients with Type 2 diabetes. The therapy is a subcutaneous injection administered weekly, and is a first-in-class medicine that activates two hormone receptors responsible for maintaining control over blood sugar levels: glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). For patients without Type 2 diabetes, tirzepatide also shows promise for weight loss when used in combination with diet and exercise.
A clinical trial last summer found that a significant percentage of patients who had a BMI of 30 or more and were treated with tirzepatide experienced “substantial and sustained reductions in body weight,” with some losing as much as 20 percent of their body weight (the mean was a 15 percent reduction in body weight after 72 weeks).
The results of the clinical trial and the FDA fast track designation has since generated a lot of media attention for tirzepatide and its weight loss potential. A physician who was one of the contributing authors on Phase 1 of the SURMOUNT clinical trial even told BuzzFeed News that if tirzepatide becomes commercially available for weight loss, it could become a household name.
Eli Lilly and Company is currently in Phase 3 of its SURMOUNT clinical development program for tirzepatide, which has enrolled more than 5,000 people with obesity or who are overweight across six clinical trials, four of which are global studies. The company anticipates results sometime this year.
“We are pleased with the FDA’s decision to grant Fast Track designation for tirzepatide, and we look forward to completing our rolling submission next year,” Mike Mason, president of Lilly Diabetes, said in a press release. “Obesity is a chronic disease that impacts the health of nearly 100 million Americans and is a significant driver of healthcare costs. While diet and exercise are important steps, most patients don’t achieve their desired treatment goals with only diet and exercise. We are dedicated to helping people living with obesity through our research and development of innovative treatments like tirzepatide, which produced significant weight reductions in patients taking tirzepatide for Type 2 diabetes in SURPASS.”
In 2021, the FDA approved Novo Nordisk’s Wegovy, a groundbreaking therapy for chronic weight management for patients who are overweight or obese and have at least one weight-related condition such as high cholesterol, Type 2 diabetes, or high blood pressure. The treatment is a weekly semiglutide (GLP-1 receptor agonist) injectable that increases insulin secretion, and was the first approved drug for chronic weight management in adults with general obesity since 2014, according to the agency. Available by prescription, Wegovy is meant for patients with a BMI of 27 or higher and is advised to be used in addition to a reduced-calorie diet and an increase in physical activity. After receiving approval, Wegovy became popular on social media and Novo Nordisk said demand for it was unprecedented and quickly outpaced supply. Since November 2022, the company has been working to make all dose strengths of the therapy broadly available at pharmacies and plans to increase its production capacity this year. Earlier this month, Wegovy also received approval for treating obesity in teens ages 12 and up.
Novo Nordisk initially developed semaglutide (under the brand name Ozempic) to treat diabetes, and discovered during a clinical trial that diabetes patients who were obese or overweight lost as much as 15 percent of their body weight as a side effect.
On the Horizon
Amgen also has a possible therapy for weight loss in the works, AMG-133. Similar to Eli Lilly’s terzepatide and Novo’s Wegovy, AMG-133 is also delivered via a subcutaneous injection and targets the GIP and GLP-1 hormone receptors. However, Amgen’s treatment has an antibody that blocks GIP, instead of boosting it. In a company announcement regarding the Phase 1 clinical data for AMG-133, David M. Reese, M.D., executive vice president of Research and Development at Amgen, said: “AMG 133 was designed based on preclinical and human genetic data that strongly suggest GIPR inhibition as a strategy for weight loss, especially in combination with GLP-1 agonism.” So far, the Phase 1 clinical data shows that patients who received the highest dose of AMG-133 experienced a 14.5 percent reduction in body weight after 12 weeks, and a 7.2 percent loss at the lowest dose. The company plans to start Phase 2 of its trial this year.