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Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2)

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 ≥ 27 kg/m2) adults with 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) ≥ 27 kg/m2

Have Type 2 Diabetes Mellitus according to the American Diabetes Association (See Section 12.5), with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Participants with HbA1c between 6.5%-6.9% or 11.0%-11.5% are allowed to have a single HbA1c retesting to confirm eligibility. Type 2 Diabetes Mellitus may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling), EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists.

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 (except for 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 Oral

    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

1

Percent change in body weight for participants with type 2 diabetes mellitus 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

Secondary outcomes

Other outcomes

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: