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Viking Therapeutics Announces Results from Phase 1 Clinical Trial of Oral Tablet Formulation of Dual GLP-1/GIP Receptor Agonist VK2735

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PR Newswire

SAN DIEGO, March 26, 2024

Up to 3.3% Placebo-Adjusted Mean Weight Loss (5.3% from Baseline) Observed After 28 Days

VK2735 Shown to be Safe and Well-Tolerated in 28-Day Study with Low Rates of GI-Related Adverse Events

Phase 2 Trial in Obesity Planned for 2H24

Conference Call Scheduled for 8:00 a.m. ET Today

SAN DIEGO, March 26, 2024 /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 positive results from the company's Phase 1 multiple ascending dose (MAD) clinical trial of an oral tablet formulation of VK2735, a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, in development for the potential treatment of metabolic disorders such as obesity. Based on these Phase 1 results, the company plans to initiate a Phase 2 trial with the oral formulation of VK2735 in obesity later this year.

Highlights from the study results include:

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Body Weight Reductions

The 28-day MAD study results highlight positive signs of clinical activity following treatment with oral VK2735. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to 5.3%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 3.3%. 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 believe these data indicate that longer treatment duration, at potentially higher doses, may result in additional weight loss. We are particularly pleased with the initial safety and tolerability data, which suggest a differentiated profile with minimal gastrointestinal-related side effects. We believe that an oral agent with good tolerability could represent an attractive potential treatment option for patients with obesity. We look forward to exploring longer treatment windows and potentially higher doses in an upcoming Phase 2 trial."

Observed Change in Body Weight Following 28 Days of Daily Dosing with Oral VK2735

Multiple Ascending Dose Level^1,2	Placebo (n=10)	VK2735 2.5 mg (n=8)	VK2735 5 mg (n=6)	VK2735 10 mg (n=6)	VK2735 20 mg (n=8)	VK2735 40 mg (n=7)
Mean baseline body weight³	94.6 kg	102.3 kg	95.3 kg	97.1 kg	111.2 kg	90.0 kg
Mean change from baseline body weight^4,5	-2.0 kg	-0.3 kg	-0.8 kg	-1.3 kg	-3.3 kg	-4.9 kg
Mean percent change from baseline^4,5	-2.1 %	-0.3 %	-0.9 %	-1.1 %	-3.2 %	-5.3 %
Placebo-adjusted mean percent change from baseline^4,5	-	1.8 %	1.2 %	1.0 %	-1.1 %	-3.3 %
p-value vs. placebo⁵	-	-	-	-	0.23	0.0006
Percent reporting ≥5% weight loss	0 %	0 %	0 %	0 %	25 %	57 %
p-value vs. placebo⁶	-	-	-	-	0.18	0.015

Notes: 1) Population includes all randomized subjects who received at least one dose of study drug and had at least one planned post-baseline body weight assessment. 2) Patients treated with VK2735 were titrated to final doses as indicated: 2.5 mg cohort = 2.5 daily x 4 weeks; 5 mg cohort = 2.5 mg daily x 1 wk, 5 mg daily x 3 wks; 10 mg cohort = 5 mg daily x 1 wk, 10 mg daily x 3 wks; 20 mg cohort = 15 mg daily x 1 wk, 20 mg daily x 3 wks; 40 mg cohort = 20 mg daily x 1 wk, 40 mg daily x 3 wks. 3) All subjects enrolled were required to have baseline BMI ≥30 kg/m². 4) Least squares mean. 5) Two-sided t test using mixed model for repeated measures. 6) Fisher's exact test.

Safety and Tolerability

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. Mild nausea was reported in five (14%) VK2735-treated subjects. Vomiting was not reported among any VK2735-treated subjects. 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. In addition, no serious adverse events (SAEs) have been reported to date.

Common GI-Related Adverse Events Following 28 Days of Daily Dosing with Oral VK2735

Common AEs,

No. of Subjects
reporting, (%)

Placebo

(n=10)

VK2735
2.5 mg

(n=8)

VK2735

5 mg

(n=7)

VK2735

10 mg

(n=6)

VK2735

20 mg

(n=8)

VK2735

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