RECRUITING

VK2735 for Weight Management Phase 3

Description

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.

Conditions

Weight Loss
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Related Conditions:

Weight Loss

Study Overview

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Study Details

Study overview

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.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

VK2735 for Weight Management Phase 3

Condition
Weight Loss
Intervention / Treatment

-

Contacts and Locations

Birmingham

Viking Clinical Site #1037, Birmingham, Alabama, United States, 35235

Huntsville

Viking Clinical Site #1128, Huntsville, Alabama, United States, 35801

Mobile

Viking Clinical Site #1081, Mobile, Alabama, United States, 36608

Chandler

Viking Clinical Site #1005, Chandler, Arizona, United States, 85210

Flagstaff

Viking Clinical Site #1017, Flagstaff, Arizona, United States, 86001

Scottsdale

Viking Clinical Site #1135, Scottsdale, Arizona, United States, 85260

Tucson

Viking Clinical Site #1019, Tucson, Arizona, United States, 85711

Chula Vista

Viking Clinical Site #1071, Chula Vista, California, United States, 91911

Escondido

Viking Clinical Site #1070, Escondido, California, United States, 92025

Huntington Park

Viking Clinical Site #1054, Huntington Park, California, United States, 90255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Viking Therapeutics, Inc.,

Study Record Dates

2027-08-01