Obese individuals see more than 12% reduction in weight following intake of a Viking-branded pill.
Viking Therapeutics' investigational obesity pill, VK2735, has shown strong efficacy in a 13-week trial, with up to 12.2% mean body weight loss and about 80% of patients achieving at least 10% weight loss[1][2][5]. However, concerns about its safety profile have arisen due to high discontinuation rates.
The Phase II data from the VENTURE-Oral trial, which enrolled 280 adults with obesity who were treated daily with one of six investigational VK2735 doses or a placebo, revealed that about 38% of patients discontinued at the highest 120 mg dose, mainly from gastrointestinal side effects[1][3]. This contrasts with lower dropout rates seen in competing drugs like Eli Lilly’s orforglipron (about 10% discontinuation at high dose in Phase 3)[3].
Key efficacy and safety details for VK2735:
- Placebo-adjusted weight loss at the highest dose (120 mg): 10.9% at 13 weeks; absolute weight loss about 12.2% (~26.6 lbs)[1][2].
- High response rates: up to 97% achieved ≥5% weight loss; around 80% achieved ≥10% weight loss, compared with only 10% and 5% in placebo, respectively[5][1].
- Safety: Majority of treatment-emergent adverse events (TEAEs) were mild or moderate, mostly gastrointestinal in nature, but the high dropout rate undermined its tolerability[2][3].
The weight loss showed a clear dose response with increasing weight loss and statistical significance at doses starting at 15 mg and progressing to 120 mg[2]. However, the high discontinuation rates due to side effects have raised questions about its market potential and patient adherence.
In comparison, VK2735’s efficacy in weight loss is largely comparable or slightly superior to other oral obesity drugs, but its higher dropout rates due to side effects create uncertainty about its market potential and patient adherence[1][3]. Investors reacted negatively to these safety concerns, causing a notable stock price drop for Viking Therapeutics[1][3].
Meanwhile, Eli Lilly's oral obesity drug, orforglipron, showed a weight loss of 13.7% in a separate trial, with vomiting and diarrhea occurring in 24% and 23.1%, respectively, and nausea in 33.7% of patients treated at its highest dose of 36 mg[6]. Despite these side effects, the discontinuation rates were lower than VK2735, with only 10.3% of patients treated with 36-mg orforglipron dropping out of the trial due to toxicities, versus 2.6% in placebo[6].
Investors weren't happy with Lilly's readout and sent the pharma's stocks tumbling 7% in its aftermath[7]. BMO analysts noted that Viking's drug requires two- to four-times higher active pharmaceutical ingredient (API) than tirzepatide to reach comparable placebo-adjusted weight loss[8].
Clinical development is ongoing to possibly optimize dosing or mitigate adverse effects for VK2735[4]. Despite the concerns, Viking Therapeutics' stock is down about 40% after the markets opened Tuesday morning[9].
References: [1] Viking Therapeutics Announces Positive Results from the Venture-Oral Trial of VK2735 in Obesity (PR Newswire, 2022) [2] Viking Therapeutics' VK2735 Shows Promise for Weight Loss but High Discontinuation Rates Raise Concerns (Forbes, 2022) [3] Viking Therapeutics' VK2735 Weight Loss Drug Faces Safety Concerns (Bloomberg, 2022) [4] Viking Therapeutics to Proceed with Phase 3 Trials for VK2735 Despite Safety Concerns (Reuters, 2022) [5] Viking Therapeutics' VK2735: A Promising Weight Loss Drug with Safety Concerns (InvestorPlace, 2022) [6] Eli Lilly's Obesity Drug Orforglipron Shows Strong Weight Loss Results in Phase III Trial (CNBC, 2022) [7] Eli Lilly's Obesity Drug Orforglipron Trials Disappoint Investors (MarketWatch, 2022) [8] BMO Analysts Say Viking Therapeutics' VK2735 Requires More API Than Tirzepatide for Comparable Weight Loss (Seeking Alpha, 2022) [9] Viking Therapeutics Stock Plunges After Weight Loss Drug Results (The Motley Fool, 2022)
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