Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)

ConditionWeight Loss

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorViking Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years of age at the time of signing the informed consent.

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.

Disqualifiers

History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation

Self-reported body weight change of 5% or more within 3 months of screening

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)

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)

Trial design

Design model

Parallel

Treatments tested in this trial

VK2735
Drug
VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily
Placebo comparator
Drug
Placebo comparator administered orally once daily

Treatment groups

560 Participants

are divided into 4 treatment groups

Group A: Placebo AssignmentPlacebo comparator 1 intervention

Group B: Active Assignment (Dose 1)Experimental treatment 1 intervention

Group C: Active Assignment (Dose 2)Experimental treatment 1 intervention

Group D: Active Assignment (Dose 3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

To demonstrate that VK2735 27.5mg, 35mg, and 55mg daily oral (each dose separately) is superior to placebo for percent change in body weight from baseline to week 68

Time frame

68 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Viking Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: