VK2735 Clinical Development
VK2735's clinical development has progressed from Phase 1 through Phase 3 with consistently positive results across both injectable and oral formulations:
- Phase 1 (2022-2023): 18 lbs weight loss in 28 days; half-life of 170-250 hours confirmed[5]
- Phase 2 VENTURE (Injectable): 14.7% weight loss at 13 weeks, 88% achieved ≥10% loss[1]
- Phase 2 VENTURE-Oral: 12.2% weight loss at 13 weeks with oral tablet[2]
- Phase 3 VANQUISH-1: ~4,650 patients enrolled, 78-week treatment, results expected 2027[3]
- Phase 3 VANQUISH-2: ~1,100 T2D patients, enrolling through Q1 2026[4]
Phase 2 VENTURE Trial (Injectable)
Design: 13-week, randomized, double-blind, placebo-controlled trial in 176 adults with obesity (BMI ≥30) or overweight (BMI ≥27) with weight-related comorbidities.
Key Results (Week 13)[1]
- Weight loss (highest dose): -14.7% from baseline
- Placebo-adjusted: -13.1% greater than placebo
- ≥10% weight loss: 88% of patients (vs. 4% placebo)
- Discontinuation rate: 13% (balanced with placebo 14%)
- Onset of effect: Statistically significant weight loss from Week 1
Weight Loss Durability
Data presented at ObesityWeek 2024 showed remarkable durability:
- 4 weeks post-treatment: Majority of weight loss maintained (p<0.0001 vs. baseline)
- 7 weeks post-treatment: Over 80% of weight loss maintained
- Implication: Supports feasibility of once-monthly maintenance dosing
Rapid Weight Loss Kinetics
VK2735's 14.7% weight loss at 13 weeks represents one of the fastest rates of weight reduction observed in obesity trials. For comparison, tirzepatide (Zepbound) achieved approximately 8-10% at 12 weeks in SURMOUNT trials. This rapid onset could improve patient adherence and motivation.
Phase 2 VENTURE-Oral Trial
Design: 13-week Phase 2 trial of once-daily oral VK2735 tablet in patients with obesity. Results announced August 2025.
Key Results[2]
- Weight loss: Up to 12.2% from baseline at 13 weeks
- Placebo-adjusted: Up to 10.9% greater than placebo
- Progressive loss: No plateau observed—suggesting potential for greater loss with longer treatment
- GI tolerability: 99% of GI adverse events mild/moderate, 90% were mild
- Serious AEs: None reported
Significance: An effective oral GLP-1/GIP agonist could significantly expand the market for obesity treatment, as many patients prefer pills to injections. Viking is earlier in oral development than competitors but has demonstrated promising efficacy.
Phase 3 VANQUISH Program
| Trial | Population | N | Duration | Status |
|---|---|---|---|---|
| VANQUISH-1 | Obesity/Overweight | ~4,650 | 78 weeks + 52w extension | Enrolled |
| VANQUISH-2 | T2D + Obesity | ~1,100 | 78 weeks | Enrolling |
VANQUISH-1 Details
- Enrollment: Completed November 2025 (ahead of schedule, above target)
- Randomization: VK2735 7.5mg, 12.5mg, 17.5mg weekly vs. placebo
- Primary endpoint: % change in body weight from baseline at 78 weeks
- Secondary endpoints: ≥5%, ≥10%, ≥15%, ≥20% responder rates
- Extension: 52-week continued treatment option
- Results expected: Late 2027
How to Enroll in VK2735 Trials
- ClinicalTrials.gov: Search "VK2735" or "Viking Therapeutics obesity"
- VANQUISH-1: Enrollment closed (completed November 2025)
- VANQUISH-2: May still be enrolling T2D patients through Q1 2026
- Eligibility: Typically BMI ≥30 (or ≥27 with comorbidities), age 18-75
Note: Viking Therapeutics is a smaller company with fewer trial sites than Eli Lilly or Novo Nordisk. Geographic options may be more limited.
FAQs
The 13-week duration was designed to efficiently demonstrate proof-of-concept before investing in longer, more expensive Phase 3 trials. VK2735's 14.7% weight loss at 13 weeks was compelling enough to justify the Phase 3 VANQUISH program. The 78-week Phase 3 trials will provide the long-term efficacy and safety data required for FDA approval.
VK2735's early weight loss is impressive:
- VK2735: 14.7% at 13 weeks
- Tirzepatide (SURMOUNT-1): ~8-10% at 12 weeks
- Semaglutide (STEP 1): ~6-7% at 12 weeks
However, final efficacy depends on the full treatment duration. Tirzepatide reached 20-22.5% at 72 weeks. We'll need to wait for VANQUISH-1 results (78 weeks) to know VK2735's comparable final efficacy.
Yes. Viking completed a Phase 2 trial of oral VK2735 tablets in August 2025, showing 12.2% weight loss at 13 weeks. The oral formulation is earlier in development than the injectable. Viking has not announced specific Phase 3 plans for the oral version, so the injectable is likely to reach market first.
Sources & References
- Viking Therapeutics. "Positive Top-Line Results from Phase 2 VENTURE Trial." February 2024. https://ir.vikingtherapeutics.com/news-releases/news-release-details/viking-therapeutics-announces-positive-top-line-results-phase-2
- Viking Therapeutics. "Positive Top-Line Results from Phase 2 VENTURE-Oral Dosing Trial." August 2025. https://www.prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-oral-dosing-trial-302533355.html
- Viking Therapeutics. "Completion of Enrollment in Phase 3 VANQUISH-1 Trial." November 2025. https://ir.vikingtherapeutics.com/news-releases
- ClinicalTrials.gov. VANQUISH-1 Trial Registry (NCT06616870). https://clinicaltrials.gov/study/NCT06616870
- Viking Therapeutics. "Phase 1 Results for VK2735." March 2023. https://ir.vikingtherapeutics.com/news-releases/news-release-details/viking-therapeutics-announces-results-phase-1-clinical-trial
Last updated October 6, 2026
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