Viking Therapeutics Announces Positive Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735 Demonstrating the Promise of Multiple Maintenance Dosing Regimens
VK2735 showed durable weight loss and effective maintenance with less frequent dosing while maintaining a tolerability profile comparable to placebo.
Rhea-AI Summary
Viking Therapeutics (VKTX) reported positive topline results from a 33-week study of GLP-1/GIP agonist VK2735 in obesity, including a 22% placebo-adjusted mean weight loss at Week 33 for the 17.5 mg once-weekly cohort, with no plateau observed.
Across 21 weeks of induction, VK2735 produced mean weight loss of approximately 16–19% versus ~0% for placebo, with 65% of treated participants achieving at least 15% weight loss and 32% achieving at least 20%. In the 12-week maintenance phase, every-other-week dosing preserved up to 97% of prior weight loss and monthly dosing up to 90%, compared with 61% for placebo, with statistically significant separation from placebo. An exploratory arm continuing 17.5 mg weekly reached 21.7% mean weight loss at Week 33. Gastrointestinal adverse event rates and discontinuations during maintenance were low and generally similar to placebo. The company plans an oral maintenance part 2 study.
Positive
- Mean weight loss 16–19% after 21 weeks of VK2735 vs ~0% for placebo
- Placebo-adjusted 22% weight loss at Week 33 with 17.5 mg weekly VK2735
- Up to 97% of weight loss maintained with every-other-week dosing vs 61% for placebo
- Up to 90% of weight loss maintained with monthly dosing vs 61% for placebo
- Exploratory arm 21.7% mean loss at Week 33 on continued 17.5 mg weekly dosing
- GI adverse event rates and discontinuations during maintenance similar to placebo
Negative
- None.
Details
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Key Figures
- Placebo-adjusted weight loss
- 22%
- Week 33 following weekly 17.5 mg VK2735 dosing
- Every-other-week weight maintenance
- 97%
- Mean Week 21 weight loss maintained at Week 33
- Every-other-week comparison
- p<0.0001
- VK2735 combined QOW versus placebo
- Monthly weight maintenance
- 90%
- Mean Week 21 weight loss maintained at Week 33
- Monthly comparison
- p=0.0002
- VK2735 monthly dosing versus placebo
- Induction-phase weight loss
- 16% to 19%
- After 21 weeks of weekly VK2735 dosing
- Study population
- approximately 180 adults
- Randomized maintenance study in adults with obesity
Previous Clinical trial Reports
-
VK2735 oral study showed dose-dependent weight loss up to 12.2%
-
VANQUISH-2 completed enrollment while maintenance data remained expected in Q3
-
Published weekly VK2735 data showed weight reductions up to 14.7%
-
VK2735 maintenance study completed enrollment across less frequent regimens
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Key Terms
pharmacokinetic technical
double-blind medical
placebo-controlled medical
treatment emergent adverse events medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Results Demonstrate Viability of Monthly and Every Other Week Dosing Regimens for Maintaining Weight Loss; Increasing Options for Adherence to Treatment
Up to
Up to
Excellent Tolerability Observed During Maintenance Dosing with GI Adverse Event Rates Similar to Placebo
Conference Call Scheduled for 8:00 a.m. ET Today
"The results of our innovative maintenance dosing study continue to demonstrate the significance of VK2735's unique and differentiated half-life and PK profile, which appear to enable an effective new approach to achieving and maintaining the weight loss goals of patients living with obesity," said Brian Lian, Ph.D., chief executive officer of Viking. "We believe this dose-ranging study clearly demonstrated the potential viability of novel, extended dosing approaches for maintenance following induction with an incretin-based therapy. We believe flexible dosing approaches will provide both patients and their providers with new options for improving long-term adherence to therapy and sustained weight management, both of which are essential to realizing the most critical benefits of weight loss, such as improved cardiovascular health, enhanced physical function, and increased quality of life. As such, we believe these results may serve to provide first-of-its-kind guidance to clinicians as they support their patients' weight loss journeys, and the important transition from weight loss induction to maintenance. Importantly, tolerability during the maintenance phase was excellent, with treated cohorts demonstrating GI-related adverse event rates that were similar to placebo. This may provide an opportunity to evaluate additional higher doses and raises the possibility of exploring both maintenance and induction weight loss with less frequent dosing regimens. Along with the oral tablet formulation, we believe these results suggest that VK2735 may provide an expanded suite of potential treatment options for patients living with obesity."
"These results are important as they provide a basis for improved dosing flexibility for both clinicians and their patients," said Louis Aronne, MD, FACP, former president of The Obesity Society and a leading voice in the obesity treatment field.1 "The cardiometabolic benefits of maintaining
Top-line study results include:
Body Weight Reductions – Induction Phase
Participants in this study were randomized to receive weekly doses of VK2735 or placebo for 21 weeks. Starting in Week 3, VK2735 doses were escalated every two weeks until final doses of 15.0 mg, 17.5 mg, 20.0 mg, or 22.5 mg were achieved. Weight loss after 21 weeks of dosing ranged from approximately
At 21 weeks in the combined VK2735 treatment groups, the proportion of participants demonstrating
Change in Body Weight Following 21 Weeks of Once-Weekly Dosing with VK2735
|
Dose Level1,2 |
Placebo (n=15) |
VK2735 15 mg QW (n=14) |
VK2735 17.5 mg QW (n=118) |
VK2735 20 mg QW (n=15) |
VK2735 22.5 mg QW (n=14) |
|
Mean baseline body weight (kg)3 |
100.0 kg |
108.4 kg |
95.9 kg |
101.9 kg |
103.0 kg |
|
Mean change from baseline body weight4,5 |
-0.1 kg |
-17.0 kg |
-17.0 kg |
-18.6 kg |
-17.2 kg |
|
Mean percent change from baseline4,5 |
-0.1 % |
-16.3 % |
-17.8 % |
-18.7 % |
-17.1 % |
|
p-value vs. baseline5 |
- |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
|
Placebo-adjusted mean percent change from baseline4,5 |
- |
-16.2 % |
-17.7 % |
-18.6 % |
-17.0 % |
|
p-value vs. placebo5 |
- |
<0.0001 |
<0.0001 |
<0.0001 |
<0.0001 |
|
|
|
Notes: 1) QW = once-weekly dosing. 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) Subjects treated with VK2735 were titrated to final doses as indicated: Week 1 = 1.25 mg; Week 2 = 2.5 mg; Week 3-4 = 5.0 mg; Week 5-6 = 7.5 mg; Week 7-8 = 10.0 mg; Week 9-10 = 12.5 mg; Week 11-12 = 15.0 mg; Week 13-14 = 17.5 mg; Week 15-16 = 20.0 mg; Week 17 = 22.5 mg. 3) All enrolled participants were required to have baseline BMI ≥30 kg/m2. 4) Least squares mean. 5) Two-sided t-test using mixed model for repeated measures. |
Body Weight Maintenance – Maintenance Phase
Following completion of the 21-week induction phase of the study, participants receiving weekly VK2735 treatment were transitioned to maintenance dosing regimens for an additional 12 weeks. During the maintenance dosing period, participants were randomized to a range of monthly (every four weeks) and every-other-week dosing regimens to evaluate the effect of less frequent dosing on weight maintenance.
Subjects randomized to every-other-week dosing regimens maintained up to
Weight Loss Maintenance Following Transition from Weekly to Every-Other-Week Dosing for 12 Weeks
|
Dose Level1,2,3 |
Placebo (n=27) |
VK2735 Combined |
VK2735 17.5 mg QW to 5.0 mg QOW (n=12) |
VK2735 15.0 mg QW to 7.5 mg QOW (n=13) |
VK2735 17.5 mg QW to 10.0 mg QOW (n=12) |
|
Mean percentage of Week 21 weight loss maintained at Week 33 (%)4,5 |
61 % |
90 % |
83 % |
90 % |
97 % |
|
p-value vs. placebo5 |
- |
p<0.0001 |
0.004 |
<0.0001 |
<0.0001 |
|
|
|
Notes: 1) QW = once-weekly dosing; QOW = once every-other-week dosing. Efficacy population, includes all randomized patients who received at least one dose of study drug on or after Week 21 and had a valid post-Week 21 body weight assessment. 2) Subjects treated with VK2735 were titrated to final doses as indicated: Week 1 = 1.25 mg; Week 2 = 2.5 mg; Week 3-4 = 5.0 mg; Week 5-6 = 7.5 mg; Week 7-8 = 10.0 mg; Week 9-10 = 12.5 mg; Week 11-12 = 15.0 mg; Week 13-14 = 17.5 mg. At Week 21 subjects were transitioned to maintenance dosing as indicated and treated for 12 weeks: 17.5 mg weekly to 5.0 mg QOW; 15 mg weekly to 7.5 mg QOW; 17.5 mg weekly to 10 mg QOW. 3) All enrolled participants were required to have baseline BMI ≥30 kg/m2. 4) Least squares mean. 5) Two-sided t-test using mixed model for repeated measures. |
Participants randomized to monthly dosing regimens successfully maintained up to
Weight Loss Maintenance Following Transition from Weekly to Monthly Dosing For 12 Weeks
|
Dose Level1,2,3 |
Placebo (n=27) |
VK2735 Combined |
VK2735 to 10 mg QM (n=16) |
VK2735 17.5 mg QW to 15 mg QM (n=14) |
VK2735 17.5 mg QW to 17.5 mg QM (n=11) |
VK2735 20 mg QW to 20 mg QM (n=14) |
VK2735 22.5 mg QW to 22.5 mg QM (n=10)6 |
|
Mean percentage of Week 21 weight loss maintained at Week 33 (%)4,5 |
61 % |
85 % |
82 % |
84 % |
90 % |
86 % |
85 % |
|
p-value vs. placebo5 |
- |
<0.0001 |
0.0016 |
0.0012 |
0.0002 |
0.0005 |
0.0024 |
|
|
|
Notes: 1) QW = once-weekly dosing; QM = once-monthly dosing. Efficacy population, includes all randomized patients who received at least one dose of study drug on or after Week 21 and had a valid post-Week 21 body weight assessment. 2) Subjects treated with VK2735 were titrated to final doses as indicated: Week 1 = 1.25 mg; Week 2 = 2.5 mg; Week 3-4 = 5.0 mg; Week 5-6 = 7.5 mg; Week 7-8 = 10.0 mg; Week 9-10 = 12.5 mg; Week 11-12 = 15.0 mg; Week 13-14 = 17.5 mg; Week 15-16 = 20.0 mg; Week 17 = 22.5 mg. At Week 21 subjects were transitioned to maintenance dosing as indicated and treated for 12 weeks: 17.5 mg weekly to 10.0 mg QM; 17.5 mg weekly to 15.0 mg QM; 17.5 mg weekly to 17.5 mg QM; 20.0 mg weekly to 20.0 mg QM; 22.5 mg once weekly to 22.5 mg QM. 3) All enrolled participants 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) Excludes subject with maintenance effect >2.5x standard deviation from cohort mean; inclusion of this subject results in |
An exploratory control arm in the study evaluated weight change in a cohort of participants who continued receiving weekly VK2735 doses of 17.5 mg (n=13). This cohort demonstrated mean weight loss of
Safety and Tolerability
VK2735 demonstrated highly encouraging tolerability during the maintenance phase of the trial following the transition from weekly dosing to every-other-week or monthly dosing regimens. Rates of GI-related adverse events such as vomiting, nausea, diarrhea, and constipation were not meaningfully different from placebo over the 12-week maintenance window. Discontinuation rates, including discontinuations due to adverse events (AEs), were low during both the maintenance and induction portions of the trial.
Discontinuations and Common Gastrointestinal TEAEs Following Transition from Weekly to Every Other Week Dosing with VK2735
|
Dose Level1,2 |
Placebo (n=27) |
VK2735 Combined (n=37) |
VK2735 5.0 mg QOW (n=12) |
VK2735 7.5 mg QOW (n=13) |
VK2735 10.0 mg QOW (n=12) |
|
Discontinued treatment early |
0 (0 %) |
1 (3 %) |
0 (0 %) |
0 (0 %) |
1 (8 %) |
|
Discontinued treatment due to adverse event |
0 (0 %) |
1 (3 %) |
0 (0 %) |
0 (0 %) |
1 (8 %) |
|
Treatment emergent adverse events (TEAEs) |
14 (52 %) |
14 (38 %) |
4 (33 %) |
5 (39 %) |
5 (42 %) |
|
Common GI AEs, # of Subjects reporting, (%) |
|
|
|
|
|
|
Nausea |
|
|
|
|
|
|
Mild Moderate Severe |
0 (0 %) 0 (0 %) 0 (0 %) |
2 (5 %) 0 (0 %) 0 (0 %) |
1 (8 %) 0 (0 %) 0 (0 %) |
1 (8 %) 0 (0 %) 0 (0 %) |
0 (0 %) 0 (0 %) 0 (0 %) |
|
Vomiting |
2 (7 %) |
1 (3 %) |
0 (0 %) |
0 (0 %) |
1 (8 %) |
|
Diarrhea |
1 (4 %) |
2 (5 %) |
0 (0 %) |
2 (15 %) |
0 (0 %) |
|
Constipation |
1 (4 %) |
0 (0 %) |
0 (0 %) |
0 (0 %) |
0 (0 %) |
|
|
|
Notes: 1) Safety population, includes all randomized subjects who received at least one dose of study drug on or after Week 21. 2) Subjects treated with VK2735 were titrated to final doses as indicated: Week 1 = 1.25 mg; Week 2 = 2.5 mg; Week 3-4 = 5.0 mg; Week 5-6 = 7.5 mg; Week 7-8 = 10.0 mg; Week 9-10 = 12.5 mg; Week 11-12 = 15.0 mg; Week 13-14 = 17.5 mg. At Week 21 subjects were transitioned to maintenance dosing as indicated and treated for 12 weeks: 17.5 mg weekly to 5.0 mg every other week (QOW); 15 mg weekly to 7.5 mg QOW; 17.5 mg weekly to 10 mg QOW. |
Discontinuations and Common Gastrointestinal TEAEs Following Transition from Weekly to Monthly Dosing with VK2735
|
Dose Level1,2 |
Placebo (n=27) |
VK2735 Combined QM (n=66) |
VK2735 10 mg QM (n=16) |
VK2735 15 mg QM (n=14) |
VK2735 17.5 mg QM (n=11) |
VK2735 20 mg QM (n=14) |
VK2735 22.5 mg QM (n=11) |
|
Discontinued treatment early |
0 (0 %) |
3 (5 %) |
0 (0 %) |
1 (7 %) |
1 (9 %) |
1 (7 %) |
0 (0 %) |
|
Discontinued treatment due to adverse event |
0 (0 %) |
1 (2 %) |
0 (0 %) |
0 (0 %) |
0 (0 %) |
1 (7 %) |
0 (0 %) |
|
Treatment emergent adverse events (TEAEs) |
14 (52 %) |
32 (49 %) |
7 (44 %) |
7 (50 %) |
5 (46 %) |
7 (50 %) |
6 (55 %) |
|
Common GI AEs, # of Subjects reporting, (%) |
|
|
|
|
|
|
|
|
Nausea |
|
|
|
|
|
|
|
|
Mild Moderate Severe |
0 (0 %) 0 (0 %) 0 (0 %) |
3 (4.5 %) 0 (0 %) 0 (0 %) |
1 (6 %) 0 (0 %) 0 (0 %) |
2 (14 %) 0 (0 %) 0 (0 %) |
0 (0 %) 0 (0 %) 0 (0 %) |
0 (0 %) 0 (0 %) 0 (0 %) |
0 (0 %) 0 (0 %) 0 (0 %) |
|
Vomiting |
2 (7 %) |
5 (8 %) |
2 (13 %) |
1 (7 %) |
1 (9 %) |
1 (7 %) |
0 (0 %) |
|
Diarrhea |
1 (4 %) |
3 (5 %) |
1 (6 %) |
0 (0 %) |
0 (0 %) |
2 (14 %) |
0 (0 %) |
|
Constipation |
1 (4 %) |
2 (3 %) |
1 (6 %) |
1 (7 %) |
0 (0 %) |
0 (0 %) |
0 (0 %) |
|
|
|
Notes: 1) Safety population, includes all randomized subjects who received at least one dose of study drug on or after Week 21. 2) Subjects treated with VK2735 were titrated to final doses as indicated: Week 1 = 1.25 mg; Week 2 = 2.5 mg; Week 3-4 = 5.0 mg; Week 5-6 = 7.5 mg; Week 7-8 = 10.0 mg; Week 9-10 = 12.5 mg; Week 11-12 = 15.0 mg; Week 13-14 = 17.5 mg; Week 15-16 = 20.0 mg; Week 17 = 22.5 mg. At Week 21 subjects were transitioned to maintenance dosing as indicated and treated for 12 weeks: 17.5 mg weekly to 10.0 mg once monthly (QM); 17.5 mg weekly to 15.0 mg QM; 17.5 mg weekly to 17.5 mg QM; 20.0 mg weekly to 20.0 mg QM; 22.5 mg once weekly to 22.5 mg QM. |
Consistent with prior clinical studies, VK2735 also demonstrated an encouraging safety and tolerability profile during the 21-week induction phase of the trial. One subject (
About the VK2735-102 Maintenance Study
The maintenance dosing study was a randomized, double-blind, placebo-controlled trial in approximately 180 adults with obesity (BMI ≥30 kg/m2) and otherwise healthy. All participants received initial weekly subcutaneous doses of VK2735 or placebo for 21 weeks. Following Week 21, participants were transitioned to a range of VK2735 maintenance dosing options including monthly, every other week, or weekly subcutaneous injections, or placebo. The objectives of the study were to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of VK2735 under these various dosing regimens. Exploratory endpoints assessed change in body weight from baseline, as well as change in body weight from Week 21 to the end of the study at Week 33.
Conference Call
Management will host a conference call to discuss top line results from the company's VK2735-102 maintenance trial today at 8:00 am Eastern. To participate in the conference call, please dial (844) 850-0543 from
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
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company advancing a next-generation portfolio of therapies for obesity and metabolic disease. Guided by deep expertise in metabolic biology and rigorous science, Viking is developing innovative treatments to help people achieve meaningful, lasting health improvements by treating obesity first. The company's lead program, VK2735, is a dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist in development in both subcutaneous and oral formulations for obesity. VK2735 is currently being evaluated in Phase 3 clinical studies for obesity, along with maintenance dosing strategies designed to support long-term weight management. Viking is also advancing additional obesity programs, including VK3019, an amylin receptor agonist, VK2809, an orally available thyroid hormone receptor beta agonist for metabolic and liver disease, and VK0214 for the rare genetic disorder X-linked adrenoleukodystrophy (X-ALD).
For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.
Notes: 1) Dr. Aronne is a paid consultant to Viking Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its clinical and preclinical development programs, anticipated timing for reporting clinical data and cash resources. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK2735, VK3019, VK0214, VK2809, and the company's other incretin receptor agonists; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.
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SOURCE Viking Therapeutics, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How was the VK2735 study structured in terms of induction and maintenance phases?
Participants first received once-weekly subcutaneous VK2735 or placebo for 21 weeks, with VK2735 titrated from 1.25 mg to final weekly doses of 15.0, 17.5, 20.0, or 22.5 mg. After Week 21, those on VK2735 entered a 12-week maintenance phase and were re-randomized to less frequent dosing: either every other week (5.0, 7.5, or 10.0 mg) or once monthly (10.0–22.5 mg), while a placebo group and an exploratory 17.5 mg weekly cohort were followed in parallel.
Who was eligible to participate in this VK2735 trial?
All enrolled participants were required to have a baseline body mass index (BMI) of at least 30 kg/m², placing them in the obese range by standard clinical criteria.
What future studies of VK2735 does Viking plan based on these results?
The company plans to explore oral maintenance dosing regimens for VK2735 in an upcoming part 2 of the current study, extending assessment beyond the subcutaneous formulation evaluated in this topline analysis.