Viking Therapeutics' Oral Obesity Drug Advances to Phase 3 Testing
💡 Key Takeaway
Viking Therapeutics' oral obesity drug moves to Phase 3, but high discontinuation rates and strong competition from Eli Lilly make it a high-risk, high-reward bet.
What Happened: Viking's Oral Obesity Drug Heads to Phase 3
Viking Therapeutics announced that its oral obesity drug, VK2735, will advance to Phase 3 clinical trials in the fourth quarter of this year. The decision follows positive feedback from an end-of-Phase 2 meeting with the FDA. VK2735 is a dual agonist targeting GLP-1 and GIP receptors, similar to Eli Lilly's Zepbound.
In Phase 2 testing, patients taking the oral version of VK2735 lost up to 12.2% of their body weight over 13 weeks, compared to just 1.3% for those on placebo. However, 20% of patients receiving the drug discontinued treatment due to side effects, versus 13% on placebo. In the highest-dose group, 38% stopped treatment.
Viking also reported that the doses planned for Phase 3 showed no meaningful difference from placebo in gastrointestinal side effects. Yet the Phase 2 data revealed a clear dose-response relationship: higher doses led to more weight loss but also more side effects.
The company's injectable version of VK2735, which is further along in development, showed up to 14.7% weight loss after 13 weeks in Phase 2. A Phase 1 study found that patients who switched to monthly shots maintained 90% of their weight loss over 12 weeks. The injectable is set to complete Phase 3 testing in July 2027.
Why It Matters: Competition and Commercial Viability
The obesity drug market is highly competitive, with Eli Lilly's Foundayo already commercialized. Foundayo, an oral weight-loss pill, achieved 11.1% weight loss over 72 weeks with only 5-10% of patients discontinuing due to side effects. This compares favorably to Viking's oral candidate, which had a 20% discontinuation rate over just 13 weeks.
Viking's oral drug may struggle to gain market share if it is less tolerable than Foundayo. Patients and prescribers often prefer treatments with fewer side effects, even if weight loss is slightly lower. The longer trial duration for Foundayo also provides more robust safety data.
Viking's injectable candidate could be a bigger opportunity. If approved, it could compete with Zepbound, especially if monthly dosing proves effective. However, the Phase 3 trials for the injectable only test weekly dosing, so the monthly advantage may not be captured.
Even if Viking succeeds in getting both formulations approved, it will enter a crowded market dominated by established players. The company's stock is likely to remain volatile as investors weigh clinical data against commercial challenges.
Source: The Motley Fool
Analysis generated by Bobby AI quantitative model, reviewed and edited by our research team. This is not financial advice. Always do your own research before making investment decisions.
Bobby Insight
Viking Therapeutics is a speculative buy for risk-tolerant investors, but wait for more Phase 3 data before committing.
The company's oral obesity drug shows efficacy but has tolerability issues that could limit adoption. The injectable candidate is promising but faces a long road to approval and tough competition. Given the binary nature of clinical trials, the stock could swing wildly on results.
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