VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

Viking Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Weight Loss

Treatments: Drug: Placebo; Drug: VK2735

Study type: Interventional

Funder types: Industry

Identifiers

NCT06828055

VK2735-202

Details and patient eligibility

About

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administered once daily.

Enrollment: 280 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), and BMI <50 kg/m2

   • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
   • BMI calculated at the Screening visit will be used to determine eligibility.

Exclusion criteria

1. History of or current clinically significant medical or psychiatric 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. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
4. Current or past diagnosis of chronic pancreatitis
5. Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 7 patient groups, including a placebo group

Placebo Assignment

Placebo Comparator group

Description:

VK2735 (Placebo) administered Daily

Treatment:

Drug: Placebo

Active Assignment (Dose #1)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Treatment:

Drug: VK2735

Active Assignment (Dose #2)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Treatment:

Drug: VK2735

Active Assignment (Dose #3)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Treatment:

Drug: VK2735

Active Assignment (Dose #4)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Treatment:

Drug: VK2735

Active Assignment (Dose #5)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Treatment:

Drug: VK2735

Active Assignment (Dose #6)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Treatment:

Drug: VK2735