VK2735 for Weight Management Phase 3 (VANQUISH 1)

Viking Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Weight Loss

Treatments: Drug: VK2735

Study type: Interventional

Funder types: Industry

Identifiers

NCT07104500

VK2735-301

Details and patient eligibility

About

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, New York Heart Association (NYHA) Functional Class I-III heart failure
   • BMI calculated at the Screening visit will be used to determine eligibility

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 (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, mucosa 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)
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4,500 participants in 4 patient groups, including a placebo group

Placebo Assignment

Placebo Comparator group

Description:

VK2735 Placebo Comparator Once Weekly

Treatment:

Drug: VK2735

Active Assignment (Dose 1)

Experimental group

Description:

VK2735 7.5mg Once Weekly

Treatment:

Drug: VK2735

Active Assignment (Dose 2)

Experimental group

Description:

VK2735 12.5mg Once Weekly

Treatment:

Drug: VK2735

Active Assignment (Dose 3)

Experimental group

Description:

VK2735 17.5mg Once Weekly

Treatment:

Drug: VK2735