Author: James Anderson

A New Ozempic? What to Know About Experimental GLP-1 Drug

Most of the treatment-related adverse effects were gastrointestinal, which is consistent with these types of drugs. Viking said most of those effects were classified as mild or moderate, though one patient experienced a severe adverse event of dehydration characterized as related to the study drug. Of the 23 patients who discontinued treatment, 18 were in the treatment groups and five were from the placebo arm. Last year, Viking reported data from a Phase 1 trial of VK2735 that tested safety and evaluated which dose to use in further testing. At that point, participants who received the highest tested dose lost about 7.8% of their body weight over four weeks. Seven people received the highest dose of 40 milligrams and experienced an average 5% weight loss from the mean baseline weight of 90 kilograms.

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Hopes for Viking’s drug have driven its shares up nearly five-fold since Jan. 1, but the news on Novo’s pill earlier this month slowed that surge. Two other companies developing pills for obesity, Pfizer and biotech Structure Therapeutics, have hit clinical setbacks in recent months as well. Ali said the side effects seen in the trial are similar to what his patients experience when taking other weight loss medications, pointing out that in the study, the side effects occurred more frequently at higher doses of the drug. The company also plans to report on the results of an early-stage clinical trial by the end of this month for an oral version of the drug, it said in the release. Strong demand for currently approved weight loss drugs such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound have made them hard to find.

For doses ≥10 mg, placebo-adjusted reductions in mean body weight were maintained or improved at Day 34, six days after the last dose of VK2735 was administered, ranging up to 3.6% relative to placebo. An exploratory assessment of the proportion of subjects achieving at least 5% weight loss after 28 days demonstrated that up to 57% of VK2735-treated subjects achieved ≥5% weight loss, compared with 0% for placebo. Based on a preliminary evaluation of weight loss trajectory, the company believes that treatment duration beyond 28 days may provide further reductions in body weight. “These Phase 1 results highlight VK2735’s promising early weight loss and tolerability profile when dosed as an oral tablet,” said Brian Lian, Ph.D., chief executive officer of Viking.

“We are excited to report the top-line results from this important Phase II study. VK2735 continues to demonstrate a promising efficacy and tolerability profile following 13 weeks of repeat dosing in obese subjects,” said Lian, in a press release. Oral VK2735 demonstrated encouraging safety and tolerability following 28 days of once-daily dosing. Among subjects receiving VK2735, all treatment emergent adverse events (TEAEs) reported to date have been mild or moderate, with the majority (76%) reported as mild. Similarly, all observed gastrointestinal (GI) adverse events have been reported as mild or moderate, with the majority (79%) reported as mild. Diarrhea was reported in one subject (3%) receiving VK2735 compared with two subjects (20%) receiving placebo. Overall, no clinically meaningful differences were reported for GI-related adverse events among subjects treated with VK2735 compared with placebo.

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  1. The weight-loss effects were greater with each higher dose tested, and the results were statistically significant, the company said.
  2. When researchers adjusted for the amount of weight lost by people in the placebo group, those receiving the drug lost 13.1% of their body weight.
  3. Analysts have suggested a takeover by a larger company could be possible, because there are few biotechs with promising obesity drugs in mid-stage clinical testing.
  4. The preliminary results reported Tuesday are from a placebo-controlled Phase 2 clinical trial that tested four doses of the Viking drug, administered as a once-weekly injection.
  5. Viking is in discussions with the FDA on next steps for the development of its drug.

Adjusted against the weight loss reported among the placebo group, the average reduction was 3.3% — a statistically significant result, Viking said. The drug is a GLP-1/GIP receptor agonist, which mimics the actions of two hormones — glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Eli Lilly’s weight loss drug Zepbound and diabetes drug Mounjaro are in the same class of drugs. Tuesday’s data revived Viking’s stock momentum, with shares climbing nearly 25% in morning trading. Analysts have suggested a takeover by a larger company could be possible, because there are few biotechs with promising obesity drugs in mid-stage clinical testing. “We believe these data indicate that longer treatment duration, at potentially higher doses, may result in additional weight loss,” said Viking CEO Brian Lian, in a statement.

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There was no plateau to the weight loss in the mid-stage study, suggesting that patients could lose even more weight with more time, Viking said Tuesday. The San Diego-based biotech plans to meet with the FDA to discuss the next steps for the drug, VK2735. Investors welcomed the news as shares of the biotech opened Tuesday at $69.77 apiece, up more than 81% from Monday’s closing price.

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Data from the Phase 2 trial, called Venture, provide a broader look at the drug’s potential. The study enrolled 176 people classified as obese or overweight who had at least one weight-related health condition. They were randomized to receive either a placebo or one of four doses of VK2735 ranging from 2.5 to 15 milligrams a week. Drugmakers are racing to develop an oral weight loss drug that works the same way, however.

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Larger phase 3 clinical trials will be needed to test the safety and effectiveness of the drug in a more diverse group of people. Viking is in discussions with the FDA on next steps for the development of its drug. However, phase 3 clinical trials will be needed before the company can apply for regulatory approval of its drug. These studies will examine the effectiveness and safety of the drug in a larger, more diverse group of people. The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.

The oral portion of the trial is a randomized, double-blind, placebo-controlled study in healthy adults with a minimum body mass index of 30 kilograms per meter squared. The primary objective of the study was to evaluate the safety and tolerability of VK2735 administered as an oral tablet once daily for 28 days. Exploratory pharmacodynamic measures included assessments of changes in body weight and other metrics. Based on the encouraging weight loss, as well as the safety and tolerability results to date, the company has elected to continue further dose escalation in this study. Viking also plans to initiate a Phase 2 trial of oral VK2735 in patients with obesity in the second half of 2024. Viking Therapeutics released results from a phase 2 clinical trial for its experimental weight loss drug.

Leerink Partners analyst Thomas Smith said in a research note that the 13.1% weight loss achieved with VK2735 compares favorably with competing drugs that activate the GLP-1 and GIP receptors, including Lilly’s Zepbound. That drug led to less than 10% absolute weight loss at all doses at the 13-week mark of its Phase 3 clinical trial. Viking’s drug will still need to show its results can be replicated in a larger a Phase 3 test. However, the greater than 13% placebo-adjusted weight reduction from VK2735 in Phase 2 exceeds the bar for success set by both Viking management and investors, Smith said. William Blair’s previous position was that the Viking drug could be clinically equivalent to Lilly’s tirzepatide, marketed as Zepbound for weight management. The Phase 1 MAD study of oral VK2735 is an extension of the company’s Phase 1 single ascending dose (SAD)/MAD trial of VK2735 administered subcutaneously.

However, VK2735 and Zepbound both imitate the naturally produced gut hormones GLP-1 and GIP, whereas Wegovy just targets GLP-1. Viking’s drug targets two insulin-stimulating hormones known as GLP-1 and GIP, similar to Lilly’s Zepbound, which targets both, and Novo’s Wegovy, which targets only GLP-1. In February, Viking announced encouraging Phase 2 trial data for an injectable version of VK2735, making it potentially competitive with the Lilly and Novo shots.