VK2735 for Weight Management Phase 2

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of VK2735 for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Conditions
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Weight Loss

Intervention / Treatment
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* Biological: VK2735
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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), and BMI <50 kg/m2 Exclusion Criteria: History of or current clinically significant medical or psychiatric 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 Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational) Current or past diagnosis of chronic pancreatitis Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened) Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: VK2735 (Placebo)<br>Placebo | Biological: Placebo<br>* Placebo comparator<br>|
| Experimental: VK2735 (Dose #1)<br>VK2735 is a peptide GLP-1 and GIP dual agonist | Biological: VK2735<br>* VK2735 is a peptide GLP-1 and GIP dual agonist<br>|
| Experimental: VK2735 (Dose #2)<br>VK2735 is a peptide GLP-1 and GIP dual agonist | Biological: VK2735<br>* VK2735 is a peptide GLP-1 and GIP dual agonist<br>|
| Experimental: VK2735 (Dose #3)<br>VK2735 is a peptide GLP-1 and GIP dual agonist | Biological: VK2735<br>* VK2735 is a peptide GLP-1 and GIP dual agonist<br>|
| Experimental: VK2735 (Dose #4)<br>VK2735 is a peptide GLP-1 and GIP dual agonist | Biological: VK2735<br>* VK2735 is a peptide GLP-1 and GIP dual agonist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent (relative) change from baseline to Week 13 in body weight | To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13 | To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obese