Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity
Viking Therapeutics (NASDAQ: VKTX) announced positive top-line results from its Phase 2 VENTURE-Oral Dosing trial of VK2735, an oral tablet formulation targeting obesity treatment. The study achieved both primary and secondary endpoints, demonstrating significant weight loss benefits.
Key highlights include: Up to 12.2% (26.6 lbs) mean weight loss in treated patients compared to 1.3% (2.9 lbs) for placebo after 13 weeks. The trial showed impressive efficacy with up to 97% of subjects achieving 鈮�5% weight loss and up to 80% achieving 鈮�10% weight loss. The drug demonstrated a favorable safety profile with 99% of GI-related adverse events being mild or moderate.
An exploratory maintenance dosing cohort showed promising results, suggesting effective weight maintenance may be achieved at lower doses (30mg) after initial treatment with higher doses.
Viking Therapeutics (NASDAQ: VKTX) ha comunicato risultati positivi di primo livello dal trial di Fase 2 VENTURE-Oral Dosing con VK2735, una formulazione orale in compressa per il trattamento dell'obesit脿. Lo studio ha raggiunto gli endpoint primari e secondari, dimostrando benefici significativi nella perdita di peso.
Punti chiave: fino al 12,2% (26,6 lb) di perdita di peso media nei pazienti trattati rispetto all'1,3% (2,9 lb) nel gruppo placebo dopo 13 settimane. Il trial ha mostrato un鈥檈fficacia importante con fino al 97% dei soggetti che ha ottenuto 鈮�5% di perdita di peso e fino all'80% con 鈮�10% di perdita. Il farmaco ha presentato un profilo di sicurezza favorevole, con il 99% degli eventi avversi gastrointestinali classificati come lievi o moderati.
Un cohorte esplorativa di dosaggio di mantenimento ha riportato risultati promettenti, suggerendo che il mantenimento del peso potrebbe essere efficace a dosi pi霉 basse (30 mg) dopo un trattamento iniziale con dosi pi霉 elevate.
Viking Therapeutics (NASDAQ: VKTX) anunci贸 resultados positivos preliminares del ensayo de Fase 2 VENTURE-Oral Dosing con VK2735, una formulaci贸n oral en comprimido para el tratamiento de la obesidad. El estudio alcanz贸 los objetivos primarios y secundarios, demostrando beneficios significativos en la p茅rdida de peso.
Puntos clave: hasta un 12,2% (26,6 lb) de p茅rdida de peso media en los pacientes tratados frente al 1,3% (2,9 lb) con placebo tras 13 semanas. El ensayo mostr贸 una eficacia notable con hasta el 97% de los sujetos alcanzando 鈮�5% de p茅rdida de peso y hasta el 80% alcanzando 鈮�10% de p茅rdida. El f谩rmaco present贸 un perfil de seguridad favorable, con el 99% de los eventos adversos gastrointestinales siendo leves o moderados.
Una cohorte exploratoria de dosis de mantenimiento mostr贸 resultados prometedores, sugiriendo que el mantenimiento del peso puede lograrse con dosis m谩s bajas (30 mg) tras un tratamiento inicial con dosis m谩s altas.
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Viking Therapeutics (NASDAQ: VKTX) a annonc茅 des r茅sultats topline positifs de son essai de phase 2 VENTURE-Oral Dosing portant sur VK2735, une formulation orale en comprim茅 destin茅e au traitement de l'ob茅sit茅. L'茅tude a atteint les crit猫res primaires et secondaires, montrant des b茅n茅fices significatifs en terme de perte de poids.
Points cl茅s : jusqu'脿 12,2 % (26,6 lb) de perte de poids moyenne chez les patients trait茅s contre 1,3 % (2,9 lb) pour le placebo apr猫s 13 semaines. L'essai a d茅montr茅 une efficacit茅 remarquable avec jusqu'脿 97 % des sujets atteignant 鈮�5 % de perte de poids et jusqu'脿 80 % atteignant 鈮�10 %. Le m茅dicament a pr茅sent茅 un profil de s茅curit茅 favorable, 99 % des 茅v茅nements ind茅sirables gastro-intestinaux 茅tant l茅gers ou mod茅r茅s.
Une cohorte exploratoire de dose d'entretien a montr茅 des r茅sultats prometteurs, sugg茅rant qu'un maintien du poids pourrait 锚tre obtenu 脿 des doses plus faibles (30 mg) apr猫s un traitement initial 脿 doses plus 茅lev茅es.
Viking Therapeutics (NASDAQ: VKTX) gab positive Topline-Ergebnisse der Phase-2-Studie VENTURE-Oral Dosing mit VK2735 bekannt, einer oralen Tablettenformulierung zur Behandlung von Adipositas. Die Studie erreichte die prim盲ren und sekund盲ren Endpunkte und zeigte signifikante Gewichtsverluste.
Wesentliche Punkte: bis zu 12,2% (26,6 lb) mittlerer Gewichtsverlust bei behandelten Patienten gegen眉ber 1,3% (2,9 lb) unter Placebo nach 13 Wochen. Die Studie zeigte eine beeindruckende Wirksamkeit mit bis zu 97% der Probanden, die 鈮�5% Gewichtsverlust erreichten, und bis zu 80% mit 鈮�10% Gewichtsverlust. Das Medikament wies ein g眉nstiges Sicherheitsprofil auf, wobei 99% der gastrointestinalen Nebenwirkungen mild oder moderat waren.
Eine explorative Erhaltungsdosis-Kohorte lieferte vielversprechende Ergebnisse und deutet darauf hin, dass eine Gewichtserhaltung nach initialer Behandlung mit h枚heren Dosen m枚glicherweise mit niedrigeren Dosen (30 mg) erreicht werden kann.
- Significant weight loss of up to 12.2% (26.6 lbs) after just 13 weeks of treatment
- High success rate with up to 97% of subjects achieving 鈮�5% weight loss
- Progressive weight loss with no plateau observed at 13 weeks, suggesting potential for greater results
- Promising maintenance results showing sustained effects at lower doses
- Strong safety profile with 99% of GI-related adverse events being mild or moderate
- Higher discontinuation rate in treatment group (28%) vs placebo (18%)
- Increased nausea rates in treated patients (58%) vs placebo (48%)
- Higher incidence of vomiting in treated subjects (26%) vs placebo (10%)
Insights
Viking's oral GLP-1/GIP drug shows impressive 12.2% weight loss in 13 weeks with good safety profile and maintenance potential.
The Phase 2 VENTURE-Oral Dosing trial results for VK2735 represent a significant clinical achievement in the obesity treatment landscape. Patients receiving the oral tablet demonstrated dose-dependent weight loss of up to 12.2% (26.6 pounds) compared to just 1.3% (2.9 pounds) with placebo after 13 weeks. Importantly, weight loss was progressive throughout the study period with no plateau observed, suggesting potential for greater reductions with longer treatment.
The drug's safety profile appears promising, with 99% of gastrointestinal adverse events categorized as mild or moderate. While nausea (58% vs 48% placebo) and vomiting (26% vs 10% placebo) were observed, their incidence decreased substantially after the third treatment week, indicating good tolerability with continued use.
What's particularly innovative is the exploratory maintenance dosing arm, where patients transitioned from 90mg to 30mg daily after 4 weeks. This group maintained and even slightly increased weight loss during the lower maintenance dose period, achieving -9.2% from baseline. This suggests a potential paradigm where patients could start on higher doses (injectable or oral) for initial weight loss, then transition to lower oral doses for long-term maintenance鈥攁ddressing a critical need in obesity treatment.
The clinical efficacy metrics are impressive, with up to 97% of treated subjects achieving 鈮�5% weight loss and up to 80% achieving 鈮�10% weight loss. These results position VK2735 as a potentially competitive entrant in the rapidly expanding GLP-1/GIP obesity treatment market.
Study Achieves Primary and Secondary Endpoints, Demonstrating Statistically Significant Reductions in Body Weight with Once-Daily VK2735 Dosing as Compared to Placebo
Up to
Exploratory Assessment of Low Dose Maintenance Treatment Demonstrates Positive Proof of Concept
VK2735 Shown to be Safe and Well-Tolerated in 13-Week Study;
Conference Call Scheduled for 8:00 a.m. ET Today
Top-line study results include:
Body Weight Reductions
Participants receiving once daily doses of the oral tablet formulation of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to
Observed Change in Body Weight Following 13 Weeks of Once-Daily Dosing with the Oral Tablet Formulation of VK2735
Dose Level1,2 | Placebo (n=40) | VK2735 15 mg (n=40) | VK2735 30 mg (n=40) | VK2735 60 mg (n=38) | VK2735 90 mg (n=39) | VK2735 120 mg (n=39) |
Mean baseline body weight (kg)3 | 105.2 kg | 99.0 kg | 102.9 kg | 102.8 kg | 103.4 kg | 101.9 kg |
Mean change from baseline body weight4,5 | -1.3 kg | -2.2 kg | -7.1 kg | -8.8 kg | -11.5 kg | -12.1 kg |
Mean percent change from baseline4,5 | -1.3听% | -2.3听% | -7.0听% | -8.7听% | -11.1听% | -12.2听% |
p-value vs. baseline5 | - | 0.0057 | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Placebo-adjusted mean percent change from baseline4,5 | - | -1.0听% | -5.7听% | -7.4听% | -9.8听% | -10.9听% |
p-value vs. placebo5 | - | - | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Percent reporting 鈮� | 5听% | 8听% | 35听% | 40听% | 59听% | 80听% |
p-value vs. placebo6 | - | - | <0.01 | 0.0017 | < 0.0001 | <0.0001 |
Notes: 1) Efficacy population, includes all randomized patients who received at least one dose of study drug and had a valid baseline and post-baseline body weight assessment. 2) Participants treated with VK2735 were titrated to final doses as indicated: 15 mg cohort = 15 mg x 13 weeks; 30 mg cohort = 30 mg x 13 weeks; 60 mg cohort = 30 mg x 2 weeks, 60 mg x 11 weeks; 90 mg cohort = 30 mg x 2 weeks, 60 mg x 2 weeks, 90 mg x 9 weeks; 120 mg cohort = 30 mg x 2 weeks, 60 mg x 2 weeks, 90 mg x 2 weeks, 120 mg x 7 weeks. 3) All enrolled participants were required to have baseline BMI 鈮�30 kg/m2 or BMI鈮�27 kg/m2 with at least one weight-related comorbid condition. 4) Least squares mean. 5) Two-sided t-test using mixed model for repeated measures. 6) Logistic regression model with treatment as factor and baseline weight as covariate. |
Safety and Tolerability
The oral tablet formulation of VK2735 demonstrated encouraging safety and tolerability following 13 weeks of once-daily dosing. Discontinuation rates due to adverse events in the VENTURE-Oral Dosing study were low and well-balanced among subjects treated with VK2735 compared with placebo. During the study
Among subjects receiving VK2735, the majority (
Discontinuation Rates and Common Gastrointestinal TEAEs Following 13 Weeks of Once-Daily Dosing with the Oral Tablet Formulation of VK2735
Dose Level1,2 | Placebo (n=40) | VK2735 15 mg (n=40) | VK2735 30 mg (n=40) | VK2735 60 mg (n=40) | VK2735 90 mg (n=40) | VK2735 120 mg (n=40) |
Treatment emergent adverse events (TEAEs) | 34 (85听%) | 35 (88听%) | 33 (83听%) | 33 (83听%) | 37 (93听%) | 36 (90听%) |
Discontinued treatment early | 7 (18听%) | 8 (20听%) | 8 (20听%) | 11 (28听%) | 10 (25听%) | 15 (38听%) |
Discontinued study early | 2 (5听%) | 4 (10听%) | 5 (13听%) | 5 (13听%) | 3 (8听%) | 5 (13听%) |
Common Drug-Related GI AEs, # of Subjects reporting, (%) | ||||||
Nausea | ||||||
Mild Moderate Severe | 16 ( 3 ( 0 ( | 12 ( 2 ( 0 ( | 15 ( 7 ( 0 ( | 13 ( 8 ( 0 ( | 22 ( 7 ( 0 ( | 15 ( 7 ( 2 ( |
Vomiting | 4 (10听%) | 2 (5听%) | 6 (15听%) | 8 (20听%) | 14 (35听%) | 14 (35听%) |
Diarrhea | 5 (13听%) | 2 (5听%) | 3 (8听%) | 6 (15听%) | 6 (15听%) | 10 (25听%) |
Constipation | 9 (23听%) | 9 (23听%) | 8 (20听%) | 12 (30听%) | 17 (43听%) | 11 (28听%) |
Abdominal pain | 1 (3听%) | 1 (3听%) | 2 (5听%) | 1 (3听%) | 1 (3听%) | 2 (5听%) |
Notes: 1) Safety population, includes all randomized subjects who received at least one dose of study drug. 2) Patients treated with VK2735 were titrated to final doses as indicated: 15 mg cohort = 15 mg x 13 weeks; 30 mg cohort = 30 mg x 13 weeks; 60 mg cohort = 30 mg x 2 weeks, 60 mg x 11 weeks; 90 mg cohort = 30 mg x 2 weeks, 60 mg x 2 weeks, 90 mg x 9 weeks; 120 mg cohort = 30 mg x 2 weeks, 60 mg x 2 weeks, 90 mg x 2 weeks, 120 mg x 7 weeks. |
The VENTURE-Oral Dosing study included an exploratory dosing cohort designed to assess weight loss maintenance. In this treatment group, participants were rapidly titrated to 90 mg daily doses. After 4 weeks of daily dosing at 90 mg, participants were down-titrated to 30 mg daily doses and maintained at 30 mg daily for 7 weeks. Weight loss in this treatment group was shown to be rapid and progressive through the 90 mg treatment period and was maintained following the transition to 30 mg daily doses. The observed results suggest that effective weight maintenance may also be achieved at doses <30 mg.
Change in Body Weight Following Transition From 90 mg Daily to 30 mg Daily
Dose Level1,2 | Baseline 102.8 kg3 | Week 3 90 mg | Week 6 90 mg4 | Week 9 30 mg | Week 13 30 mg 听 |
Mean change from baseline body weight5,6 | - | -5.2 kg | -8.1 kg | -8.8 kg | -9.1kg |
Mean percent change from baseline5,6 | - | -5.1听% | -8.1听% | -8.8听% | -9.2听% |
Placebo-adjusted mean percent change from baseline5,6 | - | -4.3听% | -6.7听% | -7.6听% | -7.9听% |
p-value vs. placebo6 | - | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
Notes: 1) Efficacy population (n=39), includes all randomized participants who received at least one dose of study drug and had a valid baseline and post-baseline body weight assessment. 2) Participants were titrated as indicated: 30 mg x 1 week, 60 mg x 1 week, 90 mg x 4 weeks, 30 mg x 7 weeks. 3) All enrolled patients were required to have baseline BMI 鈮�30 kg/m2 or BMI 鈮�27 kg/m2 with at least one weight-related comorbid condition. 4) Transition to 30 mg occurred following completion of Week 6 dosing. 5) Least squares mean. 6) Two-sided t-test using mixed model for repeated measures. |
"We are excited to report the top-line Phase 2 study results for the once-daily oral tablet of VK2735," said Brian Lian, Ph.D., chief executive officer of Viking. "As in prior studies we observed a clear dose response and impressive weight loss across the 13-week treatment period. The progressive nature of the weight loss curves suggests the potential for further improvement with longer dosing periods. The experimental maintenance arm of this study provides an encouraging signal that supports our belief that transitioning patients from higher doses, injectable or oral, to low oral doses represents a promising approach to weight maintenance therapy. We look forward to exploring this further in an upcoming maintenance dosing study."
The Phase 2 VENTURE-Oral Dosing Trial was a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial enrolled 280 adults who are obese (BMI 鈮�30 kg/m2), or adults who are overweight (BMI 鈮�27 kg/m2) with at least one weight-related co-morbid condition. Enrolled patients were evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study was the percent change in body weight from baseline after 13 weeks of treatment, while secondary and exploratory endpoints evaluated a range of additional safety and efficacy measures.
Conference Call
Management will host a conference call to discuss top-line results from the company's Phase 2 VENTURE-Oral Dosing trial today at 8:00 am Eastern. To participate in the conference call, please dial (844) 850-0543 from the
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both.听Semaglutide is a GLP-1 receptor agonist that has been approved by the
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Data from a Phase 1 and a Phase 2 trial evaluating subcutaneous VK2735 demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 2 trial in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta听agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual听amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta听agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.
For more information about Viking Therapeutics, please visit听www.vikingtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the
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