According to eagerly anticipated findings from a recent study, pharmaceutical firm Eli Lilly announced that a drug its researchers created led to substantial weight reduction in individuals who are overweight or obese but not diabetic.
This medication, named orforglipron, varies from Lilly’s injectable treatment, tirzepatide (marketed as Mounjaro for and Zepbound for and certain forms of ). Tirzepatide acts on two hormones, GLP-1 and GIP, whereas orforglipron exclusively targets GLP-1. Lilly and rival pharmaceutical companies have been striving to produce oral weight-loss medications, as weekly injections can be undesirable for patients.
The study involved over 3,100 adults who were overweight or obese, possessing an obesity-related medical condition but not diabetes. Participants who took the daily pill for nearly 18 months experienced an average weight loss of 12% of their body weight, equating to 27 pounds. Individuals on a placebo, in contrast, lost slightly more than two pounds. While these results are not yet published in a peer-reviewed journal, they are scheduled for presentation in September at the European Association for the Study of Diabetes’s annual conference.
Based on these outcomes, Lilly stated its intention to seek approval for orforglipron from the U.S. Food and Drug Administration for obesity treatment before year-end. Should it gain approval, Lilly anticipates making the pills available by the following year. The company is awaiting comprehensive findings from a parallel weight-loss study in diabetic patients; data released in April suggested the drug assisted individuals with diabetes in reducing their blood sugar levels.
Dr. Dan Skovronsky, Lilly’s chief scientific officer, commented, “The outcomes we obtained are as favorable as can be attained with an oral small molecule GLP-1. The safety, tolerability, and effectiveness were consistent with what we achieved with the injectable medication, but are now provided in a convenient, once-daily pill.”
Skovronsky highlighted that among participants in the study who received the drug, cardiac disease risk factors including, triglycerides, blood pressure, and a marker of, also decreased. This reinforces prior data indicating that GLP-1 medications can similarly reduce heart disease risk.
Similar to the injectable version, individuals taking the pills were required to gradually escalate their dosage until reaching the maximum, primarily to alleviate gastrointestinal side effects. Within the study, participants began with 6 mg, escalated to 12 mg after four weeks, and then to the 36 mg maintenance dose four weeks subsequent to that.
Skovronsky stated that orforglipron’s side effect pattern mirrored that of injectable drugs, which he found encouraging. He remarked, “I had two primary concerns. Firstly, taking something orally exposes the stomach and intestines to a greater drug concentration. If side effects originate there, the oral form might exacerbate them. However, this proved not to be the situation.”
Furthermore, the implications of missed doses by study participants were uncertain, given the occasional difficulty of daily pill adherence. Due to the meticulous dose titration, Skovronsky noted it was unknown if individuals missing pills for several days would lose their developed tolerance to side effects and need to restart their dosing regimen. He reported, “We observed that the side effects resembled those of injections, despite occasional missed doses.”
Novo Nordisk, a rival company producing Ozempic for diabetes and Wegovy for weight control, also possesses an oral version of its active compound, semaglutide, which is already. The company has sought approval for treating obesity in non-diabetic individuals and anticipates a ruling before the year concludes.
Should orforglipron receive approval, it could enhance the availability of GLP-1 medications across the U.S. and globally. The oral drug is more economical than the injectable form, as it bypasses the need for a sterile injection pen. Additionally, some individuals are hesitant about weekly self-injections, making an oral administration a desirable alternative.
As medical professionals and patients increasingly determine optimal GLP-1 drug usage for weight management, a pill could either initiate weight loss or serve as a component of a sustained maintenance plan for those who have reached their target weight. Skovronsky stated, “This allows us to intervene earlier in the disease progression, as individuals sometimes postpone injections until the condition – obesity, in this instance – becomes more severe. Our aim is to address obesity at its initial phases, and this presents an excellent chance to do so.” Skovronsky added that Lilly is also investigating weight-maintenance strategies using orforglipron.