Viking Therapeutics Highlights Clinical Data from VK2735 Obesity Program in Presentation at ObesityWeek® 2025

Rhea-AI Summary

Viking Therapeutics (NASDAQ: VKTX) presented exploratory Phase 2 VENTURE data for subcutaneous VK2735 at ObesityWeek 2025 showing improvements in cardiometabolic status after 13 weeks.

Key findings: 78% of VK2735-treated prediabetic patients shifted to normoglycemic vs 29% placebo (p=0.0008); 68% of patients with metabolic syndrome no longer met criteria vs 38% placebo (p=0.02). Up to 14.7% mean body-weight reduction and up to 88% achieved ≥10% weight loss; most drug-related TEAEs (92%) were mild or moderate. Viking also highlighted the Phase 3 VANQUISH-1 trial design.

Positive

• Prediabetes reversal: 78% shifted to normoglycemic at Week 13 (combined VK2735)
• Metabolic syndrome reversal: 68% shifted to no MetS at Week 13 (combined VK2735)
• Weight loss: mean reductions up to 14.7% at 13 weeks; up to 88% achieved ≥10% weight loss
• Safety profile: 92% of drug-related TEAEs were mild or moderate

Negative

• Results are from a 13-week exploratory analysis with limited duration
• Dose-level significance varied: 10 mg prediabetes p=0.0697 and some MetS dose p-values >0.05
• Safety detail limited to severity distribution; specific adverse-event rates not provided

Insights

Clinical Data Strategist

Phase 2 VENTURE exploratory data show rapid cardiometabolic improvements and substantial weight loss after 13-week VK2735 treatment.

VK2735 demonstrated clear, measurable shifts in glycemic and metabolic status within the study timeframe. 78% of treated patients who were prediabetic at baseline shifted to normoglycemic by Week 13 versus 29% for placebo (p=0.0008). Across MetS patients, 68% of VK2735-treated participants no longer met MetS criteria at Week 13 versus 38% for placebo (p=0.02). Prior VENTURE results reported weight reductions up to 14.7% and up to 88% of treated patients achieving ≥10% weight loss.

The business mechanism links rapid metabolic improvements to the dual GLP-1/GIP receptor agonism of VK2735 and observable clinical endpoints. Key dependencies include persistence of effects beyond 13-week treatment and reproducibility in Phase 3. Watch the ongoing Phase 3 VANQUISH-1 readouts and confirmed endpoint analyses over the next 12–36 months for durability and safety signals.

VENTURE Study Exploratory Analysis Shows VK2735 Improved Cardiometabolic Parameters After 13 Weeks; Reducing Prediabetes and Metabolic Syndrome

SAN DIEGO, Nov. 6, 2025 /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 that new clinical data from the company's VK2735 obesity program were highlighted in a poster presentation at ObesityWeek^® 2025, the annual meeting of The Obesity Society.  VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors being developed for the potential treatment of various metabolic disorders.  Viking is evaluating both subcutaneous and oral formulations of VK2735 in clinical trials. 

Results of an exploratory analysis of data from the company's Phase 2 VENTURE clinical trial of VK2735 dosed as a weekly subcutaneous injection were presented in a poster session on Thursday afternoon.  The exploratory analysis evaluated the impact of VK2735 treatment on the prevalence of prediabetes and metabolic syndrome (MetS) following the 13-week study.  Treatment with VK2735 was shown to improve cardiometabolic parameters in patients, including reductions in the prevalence of prediabetes and MetS at the end of the 13-week treatment period.

Data from the study showed that 78% of VK2735-treated patients who were characterized as prediabetic at baseline had successfully shifted to normal glycemic status at Week 13, as compared to 29% for placebo patients (p=0.0008). 

Shift in Diabetes Status from Baseline to Week 13

Parameter1	Placebo	VK2735 2.5 mg	VK2735 5 mg	VK2735 10 mg	VK2735 15 mg	Combined VK2735 Arms
Prediabetic at baseline2	14	21	21	16	16	74
Number shifting to normoglycemic at Week 133(%)	4 (29 %)	17 (81 %)	16 (76 %)	10 (63 %)	15 (94 %)	58 (78 %)
p-value vs. placebo4	-	0.0036	0.0078	0.0697	0.0023	0.0008

Notes: 1) Observed values, no imputation for missing data. 2) Defined as patients with fasting plasma glucose 100 mg/dL to 125 mg/dL or HbA1c 5.7% to 6.4%. 3) Defined as fasting plasma glucose <100 mg/dL or HbA1c <5.7%. 4) Logistic regression model with treatment as the factor and baseline blood glucose as the covariate.

Similarly, 68% of VK2735-treated patients who met the criteria for MetS at baseline were no longer considered to have the syndrome at Week 13, as compared to 38% for placebo patients (p=0.02).

Shift in Metabolic Syndrome (MetS) Status from Baseline to Week 13

Parameter1	Placebo2	VK2735 2.5 mg2	VK2735 5 mg2	VK2735 10 mg2	VK2735 15 mg2	Combined VK27352 Arms
MetS at baseline3	16	21	21	13	10	65
Number shifting to no MetS at Week 13(%)	6 (38 %)	14 (67 %)	14 (67 %)	10 (77 %)	6 (60 %)	44 (68 %)
p-value vs. placebo4	-	0.1102	0.0217	0.0182	0.3892	0.0244

Notes: 1) Observed values, no imputation for missing data. 2) Includes all participants who met the criteria for MetS at baseline and enough MetS component Week 13 data collected to determine MetS status at end of study. 3) Defined as the presence of three or more metabolic abnormalities such as: a) waist circumference of more than 40 inches in men and 35 inches in women; b) serum triglycerides level of 150 mg/dL or greater; c) high-density lipoprotein cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women; d) elevated fasting glucose of l00 mg/dL or greater; e) systolic blood pressure of 130 mm Hg or higher or diastolic blood pressure of 85 mm Hg or higher. 4) Logistic regression models with treatment as the factor and baseline specified metabolic data as the covariate.

These findings were reported at ObesityWeek in a poster presentation entitled, "Impact of Subcutaneous VK2735 on Weight, Prediabetes, and Cardiometabolic Status: The VENTURE Study."

"The results of these analyses add another important layer to the impressive overall data reported from our Phase 2 VENTURE clinical trial.  Treatment with VK2735 rapidly improved glycemic status after the 13-week treatment period suggesting the potential to reduce the risk of transitioning from prediabetic to diabetic status.  The results also show VK2735's potential to help those with metabolic syndrome reverse the condition and potentially reduce the accompanying risk of cardiovascular disease," said Brian Lian, Ph.D., chief executive officer of Viking. "These data speak to the potential for VK2735 to improve patients' overall cardiometabolic health in addition to providing significant weight loss."

A second ObesityWeek presentation highlighted the design of Viking's ongoing Phase 3 VANQUISH-1 study of subcutaneous VK2735 in patients with obesity or who are overweight with at least one weight-related co-morbid condition.  This presentation was titled: "VANQUISH-1 Study Design: Phase 3 Trial of Subcutaneous VK2735 in Adults with Overweight or Obesity."  The VANQUISH-1 study will evaluate changes in body weight as a primary endpoint as well as improvements in physical function, mental health, and productivity among patients receiving VK2735 as compared to placebo.

As previously reported by Viking, patients receiving weekly doses of VK2735 in the VENTURE study demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to 14.7% from baseline. Statistically significant differences compared to both baseline and placebo were observed for all doses starting at Week One and continuing throughout the 13-week treatment period. Reductions in body weight were progressive through the course of the study, with no plateau observed for weight loss at 13 weeks. In addition, up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo.

Additionally, as previously reported, the VENTURE study showed VK2735 treatment to have encouraging safety and tolerability following the 13-week treatment period with the majority (92%) of drug related treatment emergent adverse events (TEAEs) being categorized as mild or moderate.

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. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic^®, Rybelsus^®, and Wegovy^®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro^® and Zepbound^®.

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 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 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 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 www.vikingtherapeutics.com.

 

 

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SOURCE Viking Therapeutics, Inc.

FAQ

What did Viking (VKTX) report about VK2735 at ObesityWeek 2025 on November 6, 2025?

Viking reported exploratory Phase 2 VENTURE data showing cardiometabolic improvements after 13 weeks, including 78% prediabetes reversal versus 29% placebo (p=0.0008) and 68% MetS reversal versus 38% placebo (p=0.02).

How much weight loss did VK2735 achieve in the VENTURE study reported by VKTX?

VK2735 produced mean body-weight reductions up to 14.7% at 13 weeks and up to 88% of treated patients achieved ≥10% weight loss.

What is the safety summary for VK2735 in the Phase 2 VENTURE data for VKTX?

The company reported encouraging safety and tolerability at 13 weeks, with 92% of drug-related TEAEs categorized as mild or moderate.

What does the VKTX Phase 3 VANQUISH-1 trial evaluate and when was it discussed?

VANQUISH-1, highlighted at ObesityWeek 2025, is a Phase 3 study of subcutaneous VK2735 in adults with overweight or obesity evaluating body-weight change as the primary endpoint and secondary measures like physical function and mental health.

How statistically robust were the VK2735 findings for prediabetes and MetS in VKTX's VENTURE study?

Combined VK2735 arms showed statistically significant shifts: prediabetes to normoglycemic (p=0.0008) and MetS reversal (p=0.0244), though some individual dose comparisons had p-values >0.05.