PRESSR: Lilly's oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity

Participants with obesity or overweight and type 2 diabetes, a population with increased difficulties losing weight, lost an average of 22.9 lbs (10.5%) on the highest dose, with A1C reduced by an average of 1.8%

Abu Dhabi, United Arab Emirates: Eli Lilly and Company LLY today announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes. In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo using the efficacy estimand.1 With the completion of ATTAIN-2, Lilly now has the full clinical data package required to initiate global regulatory submissions for orforglipron.

"Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety, and tolerability profile consistent with the injectable GLP-1 class," said Louis J. Aronne, MD, FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, and world-renowned obesity specialist. "Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results."

In the ATTAIN-2 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 22.9 lbs (10.5%) at 72 weeks using the efficacy estimand. In a key secondary endpoint, orforglipron lowered A1C by 1.3% to 1.8% from a baseline of 8.1% across doses. In another key secondary endpoint, 75% of participants taking the highest dose of orforglipron achieved an A1C ≤6.5%, which is at or below the American Diabetes Association's definition of diabetes.2 Additionally, orforglipron showed clinically meaningful benefits across key cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure and triglycerides. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels, a marker of inflammation, by 50.6%.

"The ATTAIN-2 results reinforce the potential for orforglipron, as a once-daily oral, to deliver meaningful weight loss and A1C reduction, consistent with similar landmark trials for injectable GLP-1s," said Kenneth Custer, Ph.D., Lilly executive vice president and president of Lilly Cardiometabolic Health. "With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting. If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally — removing barriers and redefining how obesity is treated around the world."

The overall safety profile of orforglipron in ATTAIN-2 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (20.1%, 31.1% and 36.4%) vs. 8.4% with placebo, vomiting (12.8%, 20.2% and 23.1%) vs. 3.8% with placebo, diarrhea (21.3%, 24.8% and 27.4%) vs. 15.0% with placebo, constipation (17.7%, 21.1% and 22.4%) vs. 7.8% with placebo, and dyspepsia (9.1%, 15.4% and 10.9%) vs. 3.5% with placebo. Treatment discontinuation rates due to adverse events were 6.1% (6 mg), 10.6% (12 mg) and 10.6% (36 mg) for orforglipron vs. 4.6% with placebo. Overall treatment discontinuation rates were balanced across the treatment groups with 19.1% (6 mg), 22.3% (12 mg) and 20.5% (36 mg) for orforglipron vs. 20.0% with placebo. No hepatic safety signal was observed.

Detailed ATTAIN-2 results will be presented at a future medical meeting and published in a peer-reviewed journal.

About orforglipron 

Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.6 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity.

About Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

إخلاء المسؤوليّة حول محتوى البيانات الصحفية

إن محتوى هذه البيانات الصحفية يتم تقديمه من قِبل مزود خارجي. ونحن لا نتحمل أي مسؤولية أو نمتلك الإذن للتحكم بمثل محتوى. ويتم تقديم هذا المحتوى على أساس ’على حاله‘ و’حسب توافره‘، ولا يتم تحريره بأي شكلٍ من الأشكال. ولن نكون نحن، ولا الشركات التابعة لنا، مسؤولين عن ضمان دقة أو تأييد أو اكتمال الآراء أو وجهات النظر أو المعلومات أو المواد الواردة في هذا المحتوى.

ويتم توفير البيانات الصحفية لأغراض إعلامية حصراً؛ ولا يقترح المحتوى أي استشارات بخصوص جوانب قانونية أو استثمارية أو ضريبية أو أي آراء بشأن ملاءمة أو قيمة أو ربحية أي استراتيجية معيّنة تتعلق بالمحافِظ أو الاستثمارات. ولن نكون نحن، أو الشركات التابعة لنا، مسؤولين عن حدوث أي أخطاء أو عدم دقة في المحتوى، أو أي إجراءات تقومون باتخاذها استناداً إلى ذلك المحتوى. وأنت توافق وتقرّ صراحة بتحمّل كامل المسؤولية عن استخدام المعلومات الواردة في هذه البيانات الصحفية.

وبموجب الحد الذي يسمح به القانون المعمول به، لن تتحمّل ’ ريفينيتيف ‘، وشركتها الأم والشركات الفرعية والشركات التابعة والمساهمون المعنيون والمدراء والمسؤولون والموظفون والوكلاء والمعلنون ومزوّدو المحتوى والمرخّصون (المشُار إليهم مُجتمعين بـ ’أطراف ريفينيتيف ‘) أي مسؤولية (سواءً مجتمعين أو منفردين) تجاهك عن أية أضــرار مباشــرة أو غيــر مباشــرة أو تبعيــّة أو خاصــة أو عرضيّة أو تأديبية أو تحذيريّة؛ وذلك بما يشمل على سـبيل المثـال لا الحصـر: خسـائر الأرباح أو خسارة الوفورات أو الإيرادات، سـواء كان ذلك بسبب الإهمال أو الضـرر أو العقـد أو نظريـات المسـؤولية الأخرى، حتـى لـو تـم إخطـار أطـراف ’ ريفينيتيف ‘ بإمكانيـة حـدوث أيٍ مـن هـذه الأضرار والخسـائر أو كانـوا قـد توقعـوا فعلياً حدوثهـا.