VK2735 for Weight Management Phase 2 (VENTURE)

Viking Therapeutics

Status and phase: Completed; Phase 2

Conditions: Weight Loss

Treatments: Biological: VK2735; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06068946

VK2735-201

Details and patient eligibility

About

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 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 weekly.

Enrollment: 176 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

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 ≥20 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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176 participants in 5 patient groups, including a placebo group

VK2735 (Placebo)

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: Placebo

VK2735 (Dose #1)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist

Treatment:

Biological: VK2735

VK2735 (Dose #2)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist

Treatment:

Biological: VK2735

VK2735 (Dose #3)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist

Treatment:

Biological: VK2735

VK2735 (Dose #4)

Experimental group

Description:

VK2735 is a peptide GLP-1 and GIP dual agonist

Treatment:

Biological: VK2735