Viking Therapeutics Advances VK2735 Obesity Drug Into Phase 3 After 15% Weight Loss

Key Points

• Viking Therapeutics has advanced VK2735 into Phase 3 after the GLP-1/GIP drug produced 14.7% weight loss over 13 weeks at the highest Phase 2 dose. Two weekly injectable trials are fully enrolled, with results expected in the second half of 2027.
• The company plans to begin Phase 3 trials of an oral VK2735 tablet in the fourth quarter, though the program is expected to trail the injectable version by 12 to 18 months. Viking is also studying whether less frequent dosing can maintain weight loss while limiting gastrointestinal side effects.
• Viking is building substantial manufacturing capacity and preparing for potential independent commercialization, while remaining open to partnerships. Its additional pipeline includes VK3019, a long-acting amylin agonist that showed greater weight loss than VK2735 in obese monkeys.

Viking Therapeutics NASDAQ: VKTX said its obesity drug candidate VK2735 has advanced into Phase 3 development following Phase 2 results that showed approximately 15% weight loss from baseline after 13 weeks at the highest tested dose.

Speaking at the Morgan Stanley Global Healthcare Conference, President and CEO Brian Lian said the company has fully enrolled two Phase 3 trials of weekly subcutaneous VK2735: VANQUISH-1 in patients with obesity and VANQUISH-2 in patients with obesity and type 2 diabetes. Viking expects both studies to report data in the second half of 2027.

The company is also developing an oral tablet formulation of the same GLP-1/GIP dual agonist. Lian said Viking plans to begin two Phase 3 studies of the oral formulation in the fourth quarter. The oral program is expected to trail the injectable program by roughly 12 to 18 months.

Multiple Formulations and Maintenance Dosing

Lian said Viking’s strategy is to offer patients options across injectable and oral formulations, potentially allowing patients to transition between the products without introducing a new molecule or a substantially different adverse-event profile.

The company is also conducting a maintenance study designed to determine whether patients can maintain weight loss after transitioning from weekly dosing to every-other-week or monthly dosing. Viking has guided to data from that study during the current quarter.

The maintenance study evaluates every-other-week doses of 5 milligrams, 7.5 milligrams and 10 milligrams, as well as monthly doses up to 22.5 milligrams. It also includes an arm that continues weekly 17.5-milligram dosing through 33 weeks.

Lian said the company will focus on several measures in the results, including weight-loss trends following the transition to less frequent dosing, tolerability during the maintenance period, and the proportion of initial weight loss maintained. He said Viking would likely report results from the 17.5-milligram weekly arm, while noting that the group includes 15 patients.

He said a key unanswered question is whether less frequent administration could reinitiate gastrointestinal side effects such as nausea, vomiting, constipation and diarrhea. Viking would view tolerability during the maintenance period as particularly important, he said, because favorable tolerability could support testing higher doses.

Phase 3 Design and Oral Program

In Phase 2, VK2735 was tested at doses up to 15 milligrams weekly, producing 14.7% weight loss from baseline after 13 weeks, according to Lian. The ongoing Phase 3 injectable studies will test doses up to 17.5 milligrams over 78 weeks.

Viking modified the Phase 3 titration schedule after observing lower nausea rates among patients who began Phase 2 treatment at 2.5 milligrams rather than 5 milligrams, Lian said. In Phase 3, patients begin at 1.25 milligrams for two weeks, advance to 2.5 milligrams for four weeks, and then increase in 2.5-milligram increments in four-week intervals.

The oral formulation produced about 12% weight loss at its 120-milligram high dose in a Phase 2 trial, Lian said. The company is reducing both tablet size and tablet count for Phase 3 after finding that four larger tablets were not a favorable experience for some patients.

Viking expects the oral Phase 3 studies to be smaller and shorter than the injectable trials. Lian said the FDA indicated that, under normal circumstances, Viking could leverage human safety data generated in the injectable Phase 3 program for the oral program because both formulations use the same molecule. That approach could reduce the total enrollment required for the oral studies by about 75% relative to the injectable program, he said.

Supply and Commercial Planning

Lian said Viking has sought to build manufacturing capacity and supply-chain redundancy in response to shortages seen in earlier obesity-drug launches. The company has a base agreement with CordenPharma for multi-ton active pharmaceutical ingredient capacity, at least 100 million vial-and-syringe units, at least 100 million auto-injector units and at least 1 billion tablets, all expandable at Viking’s option.

Since announcing the CordenPharma agreement in March 2025, Viking has added three additional multi-ton API manufacturers, Lian said.

Chief Commercial Officer Neil Aubuchon said Viking remains open to strategic collaborations but is planning its business as though it would commercialize products itself. He cited the potential for commercial efficiencies from marketing injectable and oral versions of the same molecule, as well as access opportunities through cash-pay channels, direct-to-employer programs and direct-to-consumer platforms.

Aubuchon also said Viking is monitoring the Medicare GLP-1 Bridge program, particularly uncertainty around what could occur in 2029. Lian said pricing will be an important variable for the obesity market, while adding that Viking has not seen material changes in FDA response times or engagement despite broader changes at the agency.

Additional Pipeline Work

Viking is also studying VK3019, a long-acting peptide amylin agonist. Lian said preclinical data in obese monkeys showed greater weight loss with VK3019 than with VK2735. The company is conducting a single-ascending-dose study and could proceed to a four-week, weekly multiple-ascending-dose study if the initial results are favorable.

On artificial intelligence, Lian said Viking has taken an incremental approach, exploring potential uses in development planning and protocol development rather than broadly applying the technology in discovery programs. Aubuchon added that consumer use of AI may also become relevant to commercial planning by the time Viking reaches the market.

About Viking Therapeutics (NASDAQ:VKTX)

Viking Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing therapies for metabolic and endocrine disorders. The company's research programs target conditions including obesity, nonalcoholic steatohepatitis (NASH), metabolic dysfunction-associated steatohepatitis (MASH), dyslipidemia and other disorders involving hormone regulation and metabolism.

Viking's lead program is VK2735, an investigational dual agonist of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors being developed in injectable and oral formulations for obesity and related metabolic conditions.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.