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Not yet recruitingNCT07868835Updated Oct 16, 2026

Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)

A Phase 3 interventional study of VK2735 and Placebo comparator in Weight Loss, sponsored by Viking Therapeutics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Viking Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Updated Oct 16, 2026Start date movedPrimary outcomes revised+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
560
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27kg/m2) adults with at least one weight-related comorbidity without type 2 diabetes mellitus.

Read the detailed description

This is a Phase 3, multicenter, 68-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 oral formulation in adults who are obese or overweight with one or more weight related comorbid conditions without Type 2 Diabetes Mellitus.

02

Conditions studied

  • Weight Loss

Keywords

  • Body Weight Changes
  • Body Weight
  • Weight Loss
03

In context

Weight Loss

1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.

This study's planned enrollment of 560 is above the median of 73 across 1,540 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Viking Therapeutics, Inc. is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years of age at the time of signing the informed consent.
  2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated).

    • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
    • Cardiovascular disease includes, for example, ischemic cardiovascular disease, NYHA Functional Class I-III heart failure.
    • BMI calculated at the screening visit will be used to determine eligibility.

Exclusion criteria

Exclusion Criteria:

  1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
  2. Self-reported body weight change of 5% or more within 3 months of screening
  3. Have a prior or planned surgical treatment for obesity such as a gastric sleeve, lap band or any form of bariatric surgery (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
  4. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
  5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes). If a participant has had gestational diabetes, they are allowed to be enrolled as long as the glycemic status has returned to normal levels after 12 months of completion of pregnancy
  6. Treatment with glucose-lowering agent(s) within 90 days before screening
  7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
  8. History of acute or chronic pancreatitis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
560 participants (estimated)

Study arms

  • Placebo comparator
    Placebo Assignment

    Placebo comparator orally once daily

    Drug: Placebo comparator

  • Experimental
    Active Assignment (Dose 1)

    VK2735 Dose level 1 orally once daily

    Drug: VK2735

  • Experimental
    Active Assignment (Dose 2)

    VK2735 Dose level 2 orally once daily

    Drug: VK2735

  • Experimental
    Active Assignment (Dose 3)

    VK2735 Dose level 3 orally once daily

    Drug: VK2735

Interventions

  • DrugVK2735

    VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily

  • DrugPlacebo comparator

    Placebo comparator administered orally once daily

06

What researchers measure

Primary outcomes

  1. Percentage change in body weight for participants receiving VK2735 orally once daily

    To demonstrate that VK2735 daily oral is superior to placebo for percent change in body weight from baseline to week 68

    Time frame: 68 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Start date
Oct 15, 2026→Nov 2026
Oct 16, 2026
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 9, 2026
Show all 2 updates
  1. Oct 16, 2026
    Start date Oct 15, 2026→Nov 2026
    Primary outcomes Revised (1 change)
    + 2 other changes: description and arm descriptions
  2. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868835
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Oct 16, 2026

Study contacts

Hubert Chen, MD
Contact
clinicaltrials@vikingtherapeutics.com
8587044660

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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