Years after approving three glucagon-like peptide-1 (GLP-1) receptor agonists to treat obesity, the U.S. FDA is acknowledging that the drugs don’t have the same risk seen with older weight-loss medicines. Citing its post-market evaluation that found no increased risk of suicidal ideation or behavior, the U.S. FDA is requesting that the risk be removed from the warnings and precautions section of labeling for the GLP-1 obesity drugs – Eli Lilly and Co.’s Zepbound (tirzepatide) and Novo Nordisk A/S’ Saxenda (liraglutide) and Wegovy (semaglutide).

There are two significant messages for companies developing and profiting from obesity drugs in a meta-analysis of clinical trials examining the extent of weight regain after treatment stops. First, people taking obesity medication regain weight four times faster on average than those who lose weight through behavioral diet and exercise programs; and second, poor tolerability leads to poor adherence.

Over the last year, diabetes technology saw significant changes, including the acceleration of patch pumps, ever-smaller continuous glucose monitors (CGM), implanted CGMs and increased interest in devices that measure additional chemicals in blood without needles.

Sustaining healthy weight loss is about much more than cutting calories or injecting drugs, as many glucagon-like peptide-1 (GLP-1) receptor agonist users are discovering. Widely seen as miracle drugs, semaglutide, tirzepatide and related medications have transformed the treatment of obesity and diabetes and apparently lessened the need for medical device intervention in many instances. However, many patients will still need surgical intervention to achieve their weight loss goals.

When glucagon-like peptide-1 (GLP-1) receptor agonists entered the market for obesity and overweight indications in recent years, the uptake and enthusiasm drove investor excitement for companies advancing any of the new mechanisms in the space.

Eli Lilly and Co. took another step toward adding a way for patients to hang onto their weight loss when the firm disclosed positive top-line data from the phase III Attain-Maintain trial with orforglipron, a once-daily oral small molecule GLP-1 receptor agonist. Indianapolis-based Lilly said that at one year orforglipron met the primary and all key secondary endpoints vs. placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity, using the efficacy estimand and modified treatment-regimen estimand.

With new results from Wave Life Sciences Ltd., Structure Therapeutics Inc. and Ascletis Pharma Inc., obesity management drugs continue to move forward in producing weight loss and move the market.

Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita procedure. Six-month results from its open-label REVEAL-1 cohort of individuals with obesity who lost 15% or more of their total body weight on a GLP-1 therapy maintained that loss after discontinuing the drugs and undergoing the Revita procedure.