Viking Therapeutics, Inc.

Dive Brief:Eli Lillys weight loss pill orforglipron succeeded in a Phase 3 clinical trial in diabetes, helping study participants control their blood sugar while hinting at weight loss that might be comparable to injectable obesity medicines. Enrollees in the 40-week trial saw their blood sugar levels reduced by up to 1.6 percentage points, with 65% achieving healthy levels, the company said Thursday. Notably, the drug spurred an average of up to 8% weight loss, or about 16 pounds, at the highest dose, indicating that the effects will be even greater in Lillys longer Phase 3 trial in obesity. Lilly said trial participants had not yet reached a weight plateau when the diabetes study ended.A pill with similar weight loss effects to injectable GLP-1 therapies like Novo Nordisks Wegovy or Lillys own Zepbound could change the dynamics of the lucrative market for obesity drugs. As a small molecule, or chemical, drug, orforglipron would also be easier to manufacture than its injectable counterparts, which have faced production constraints that have limited uptake.Dive Insight:Orforglipron is one of the most closely watched drugs in the pharmaceutical industry. If successful in additional late-stage trials, it could offer people with diabetes or obesity a convenient, oral alternative to injectable therapies and quickly be scaled into mass production.The drug could also give Lilly a bigger share of a market estimated to top $100 billion annually by next decade. Lillys already made significant inroads on that front, with Zepbound outperforming Wegovy in a head-to-head trial. It could further press its top rival with orforglipron, which is expected to produce Phase 3 results in obesity later this year and could be submitted to regulators afterwards. Novo, by comparison, hasnt sought approval in obesity for an oral peptide drug called Rybelsus thats shown it can stimulate weight loss.One of Lillys top competitors, Pfizer, also suffered a significant setback earlier this week, when it abandoned development of a rival pill called danuglipron.The diabetes trial toplined Thursday, Achieve-1, enrolled 559 people with Type 2 diabetes and randomized them to receive one of three daily doses of orforglipron or a placebo. The people in the drug arms started with just a 1 milligram dose of orforglipron and gradually increased to their assigned dose of 3, 12 or 36 milligrams.Blood sugar reductions, from 8% on average at the studys start,were 1.3, 1.6 and 1.5 percentage points respectively in the 3, 12 and 36 mg groups, compared to a 0.1 percentage point reduction in the placebo group. Trial participants, who had a baseline mean body weight of 199 pounds, lost 4.7%, 6.1% and 7.9% of their weight on the three doses, versus 1.6% in those receiving a placebo.Orforglipron was associated with the same gastrointestinal side effects commonly seen with GLP-1 therapies. Notably, though, the rates of such side effects appear to be lower than what Lilly observed in earlier testing, which could be attributed to the gradual dosing increase in the Phase 3 study, wrote Evercore ISI analyst Umer Raffat.Elevated liver enzymes, a sign of possible organ damage, had also been seen in earlier testing. Though Lilly didnt provide specific details, it did say Thursday that no hepatic safety signal was observed.In a separate research note, Leerink Partners analyst David Risinger called the results picture perfect. Though the data are from a shorter trial in diabetes, the drugs safety and efficacy appear comparable to Novos drug, Risinger wrote. Multiple analysts had a similarly positive take, arguing orforglipron could set the standard for oral obesity drugs.The results have implications for others following with such medicines. Structure Therapeutics is developing a small molecule GLP-1 pill, while Viking Therapeutics and Zealand Pharma have peptide counterparts that could be at a disadvantage. And Novo, without a viable oral drug, may start facing tougher competition next year should orforglipron get to market for obesity and diabetes, Jefferies analyst Benjamin Jackson wrote.Lilly shares rose nearly 15% in morning trading, swelling its market value by more than $100 billion. '

Baqsimi was launched as an option to provide rescue treatment for diabetes patients who take insulin. Credit: Diabetesmagazijn.nl on Unsplash. Eli Lilly’s Phase III trial with its oral weight loss pill, orforglipron, has met its primary endpoint, reducing A1C levels by up to 1.6%. In the first of several readouts expected from a Phase III programme, Lilly said its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) demonstrated significant efficacy while maintaining a safety profile consistent with subcutaneously delivered GLP-1RA drugs. Eli Lilly’s stock jumped up by 13.8% at market open today (17 April). The company has a market cap of $659.93bn. This news comes just days after Pfizer culled its second obesity pill due to a liver injury incident in a patient . The manageable safety profile of Lilly’s drug marks an important development in the field of oral GLP-1RAs . Based on this update and other trials from the programme that are due to read out later this year, Lilly expects to submit an approval application for orforglipron as a weight management treatment to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes (T2D) anticipated in 2026. If it gains market approval, GlobalData predicts sales of orforglipron to reach $11.8bn in 2030. The global GLP-1RA market is experiencing substantial growth and is projected to reach $125bn by 2033. GlobalData is the parent company of Clinical Trials Arena . Efficacy and safety proven in first study In the randomised, placebo-controlled, double-blind ACHIEVE-1 trial (NCT05971940), the efficacy and safety of three doses – 3mg, 12mg and 36mg – of orforglipron were evaluated in adults with T2D and inadequate glycemic control with diet and exercise alone. The drug reduced A1C levels by an average of 1.3% to 1.6% from a baseline of 8.0% after 40 weeks. It also scored in a key secondary endpoint, with more than 65% of participants taking the highest dose of orforglipron achieving an A1C less than or equal to 6.5%, which is below the American Diabetes Association’s (ADA) defined threshold for diabetes. Finally, there was significant weight loss achieved in the study, with patients losing an average of 16lb (7.9%) in the highest dose cohort. This weight loss had not plateaued, indicating potential further weight loss could be possible with further dosing. Meanwhile, the placebo cohort saw an average weight loss of 3.4lb. In addition to the efficacy, Lilly has also touted that orforglipron’s safety profile in ACHIEVE-1 and said it was consistent with the established GLP-1RA class, with the most commonly reported adverse events (AEs) being gastrointestinal-related and generally mild to moderate in severity. No hepatic safety signal was observed. Treatment discontinuation rates due to AEs were 6% in the low-dose group, 4% in the medium-dose cohort and 8% in the high-dose group compared to 1% with placebo. A Bank of America Securities report said that the four main parameters for assessing orforglipron were weight loss, blood sugar control, tolerability and safety, describing the data for all these as “solid”. This data readout was viewed as a closely watched event, and all eyes are now on Novo Nordisk’s oral GLP-1RA drug Rybelsus, which is approved for T2D, but not for weight management. The report said Rybelsus is a peptide with certain limitations, while orforglipron, being a small-molecule drug, could be easy to scale and produce. Eli Lilly’s CEO David Ricks said: “As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale for use by people around the world. We look forward to additional data readouts later this year.” Lilly states that orforglipron is the first oral small molecule GLP-1RA, taken without food and water restrictions, to successfully complete a Phase III trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints, something that until recently has plagued the GLP-1RA market . Data is set to be presented at ADA’s 85th Scientific Sessions in June 2025 and published in a peer-reviewed journal. Lilly already a powerhouse in the weight loss space Eli Lilly has already cemented its name in the GLP-1RA space with its subcutaneous therapy, tirzepatide, which is marketed as Mounjaro for T2D and Zepbound for obesity. GlobalData predicts a global sales forecast for tirzepatide of $26.75bn in 2030. Its main competitor in the space currently is Novo Nordisk, which is also a high flier with its GLP-1RA semaglutide, marketed as Ozempic for T2D and Wegovy for weight loss. Other companies are trying to break into the space, including Viking Therapeutics, which is set to initiate trials of VK2735, with the subcutaneous formulation set to enter a Phase III trial in Q2 2025 and the oral version in an ongoing Phase II study (NCT06828055). While Pfizer pulled its oral candidate, danuglipron, from development earlier this week, the company does have another obesity pill – PF-07976016, which is in a Phase IIa trial.

Conference Call Scheduled for Wednesday, April 23 at 4:30 p.m. Eastern Time SAN DIEGO, April 16, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the company will release financial results for the first quarter 2025 after the market close on Wednesday, April 23, 2025. The company will host a conference call to discuss financial results and general corporate updates beginning at 4:30 p.m. Eastern Time on Wednesday, April 23, 2025. To participate on the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until April 30, 2025, by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering replay access code #8779272. Those interested in listening to the conference call live via the internet may do so by visiting the Webcasts page of Viking's website at . An archive of the webcast will also be available on the Webcasts page of the company's website for 30 days. About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 2 trial. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo. For more information about Viking Therapeutics, please visit . SOURCE Viking Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED