Oral VK2735 Phase 3: what Viking’s two SUNRISE trials will test

Why SUNRISE needs two trials

SUNRISE 1 and SUNRISE 2 divide the question by diabetes status.[2][3] Each is a randomized study at multiple centers, with participants and investigators unaware of the assigned treatment. Three groups will receive different studied levels of oral VK2735; a fourth will receive placebo.[2][3]

SUNRISE 1, registered as NCT07868835, excludes type 2 diabetes.[2][3] Its entry criteria include adults with a body mass index of at least 30, or at least 27 with a condition related to weight, such as high blood pressure or obstructive sleep apnea. SUNRISE 2, NCT07868939, requires type 2 diabetes and a body mass index of at least 27.[2][3]

The second study also specifies blood sugar criteria and stable background treatment.[3] Those requirements define a different study population, rather than simply adding a diabetes subgroup to the first trial. Each trial is intended to produce its own comparison with placebo.[3]

That separation matters when results arrive.[2][3] The same tablet and endpoint will be studied in both groups, but a difference between their headline results would not by itself prove that diabetes caused a difference in response. Participants are randomized within each trial, not between the two populations.[2][3]

What the 68 week endpoint will answer

The primary endpoint is the percentage change in body weight from the start of treatment to week 68.[2][3] Each studied level of VK2735 will be compared separately with placebo. The placebo comparison is essential: a change from starting weight in an active group alone does not isolate the treatment’s effect.[2][3]

A mean weight change summarizes a group.[1] It cannot show how consistently people respond. Viking says the program will also examine the proportions reaching weight reduction thresholds of at least 5%, 10%, 15% and 20%. Those are planned measures, not outcomes already achieved in SUNRISE.[1]

Neither study includes an approved weight management medicine as its active comparator.[2][3] A positive result could establish an advantage over placebo under the trial conditions, but would leave a direct comparison with another medicine unanswered. That distinction will matter if future headlines put SUNRISE beside results from unrelated trials.[2][3]

A longer test than oral VENTURE

The preceding oral VENTURE Phase 2 study enrolled 280 participants and set its primary weight endpoint at 13 weeks.[2][3][4] SUNRISE extends the planned treatment period to 68 weeks and targets a larger enrollment in each of its two populations. The earlier study is registered as NCT06828055.[2][3][4]

Viking reported weight reductions compared with placebo in the earlier trial.[1] Its October announcement also describes gastrointestinal events as the most commonly observed treatment emergent adverse events. Both the efficacy account and the tolerability description come from the developer of VK2735.[1]

Over 68 weeks, weight change and treatment tolerability become connected questions.[1][2][3] Participants who stop treatment or miss measurements can affect how the eventual weight results are interpreted. Reporting withdrawals and adverse events alongside weight trajectories will help explain the experience of staying in treatment.[1][2][3]

The SUNRISE records describe safety and tolerability assessment alongside weight outcomes.[2][3] Their currently posted outcome modules list the primary weight endpoint but do not specify the safety assessment schedule.[2][3]

The tablet and injection have separate evidence

VK2735 is designed to activate the receptors for glucagon like peptide 1, or GLP 1, and glucose dependent insulinotropic polypeptide, or GIP.[1][2][3] An agonist activates a receptor. The oral study records identify VK2735 as a peptide dual agonist, meaning it acts at both receptor types.[1][2][3]

Viking is developing an injected formulation as well as the tablet.[1] Its separate VANQUISH Phase 3 program studies the injected form over 78 weeks, compared with SUNRISE’s 68 weeks of oral treatment. Each formulation will have its own results from those different treatment courses.[1]

The company is also studying maintenance treatment separately.[1][2][3] SUNRISE tracks weight change during treatment. Following people after withdrawal addresses a different question: how much of a change persists once treatment ends. The GLP 1 withdrawal pilot illustrates a study designed around that question.[1][2][3]

Program launch and recruitment are different milestones

Viking announced initiation of the oral program on October 14.[1][2][3] The ClinicalTrials.gov records last posted on October 9 still listed both studies as not yet recruiting in the October 15 morning snapshot. The estimated start dates were October 15 for SUNRISE 1 and October 16 for SUNRISE 2. These records do not document a first participant receiving treatment.[1][2][3]

The estimated primary completion dates are July 2028 for SUNRISE 1 and October 2028 for SUNRISE 2.[2][3] Primary completion refers to collection of the data needed for the primary endpoint. It is not a promised date for a public results announcement, an approval decision or commercial availability.[2][3]

SUNRISE gives Viking’s tablet a longer test in two defined populations.[1][2][3] Updated recruitment records will show its operational progress. The eventual weight results, interpreted alongside treatment completion and adverse events, will show whether the earlier signal becomes a sustained effect in each of the two populations.[1][2][3]

Sources and further reading

1. Viking Therapeutics: oral VK2735 Phase 3 program announcement, October 14, 2026
2. SUNRISE 1: ClinicalTrials.gov NCT07868835
3. SUNRISE 2: ClinicalTrials.gov NCT07868939
4. Oral VENTURE Phase 2: ClinicalTrials.gov NCT06828055

Related reading

• EB613 and the choice of a Phase 3 endpoint
• Amylin and GLP 1: different hormone pathways