What side effects are associated with this type of intervention?

Common treatments for weight loss, such as fenfluramine plus phentermine and setmelanotide, often have side effects including nausea, vomiting, dry mouth, dizziness, and injection site reactions. In long-term studies, fenfluramine plus phentermine was associated with dry mouth and occasional medication-related dropouts due to adverse effects or lack of efficacy. Setmelanotide commonly caused injection site reactions and skin disorders but did not result in serious treatment-related adverse events. These side effects are important considerations for patients and healthcare providers when evaluating weight loss treatment options.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for weight loss management in adults. These include orlistat, which reduces fat absorption; phentermine-topiramate, a combination that suppresses appetite; and liraglutide, a GLP-1 receptor agonist that increases satiety. Additionally, naltrexone-bupropion, which affects appetite regulation and energy balance, and lorcaserin, which was withdrawn due to cancer risk, have also been used. These treatments aim to support weight loss through various mechanisms such as appetite suppression, increased satiety, and reduced fat absorption.

What other types of research exist?

Promising novel alternatives to VK2735 for weight loss patients include tirzepatide, a once-weekly GLP-1 receptor agonist that has shown significant weight loss in clinical trials, and semaglutide, another GLP-1 receptor agonist approved for chronic weight management. Both drugs have demonstrated substantial efficacy in reducing body weight in patients with obesity or overweight conditions.

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VK2735 for Obesity (VENTURE Trial)

Phase 2

Waitlist Available

Research Sponsored by Viking Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years of age at the time of signing the informed consent

Be older than 18 years old

Must not have

Current or past diagnosis of chronic pancreatitis

Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 weeks

Summary

This trial is testing a treatment called VK2735 to help adults who are overweight or obese lose weight. The study focuses on people who also have other health issues related to their weight. Researchers want to see if VK2735 is safe and effective for weight loss.

Who is the study for?

This trial is for adults over 18 with obesity (BMI ≥30) or overweight (BMI ≥27) with a weight-related condition, but not heavier than a BMI of 50. It's not for those who've had significant weight changes recently, have diabetes or chronic pancreatitis, used certain drugs for weight loss in the past 6 months, or have specific medical conditions that could affect their participation.

What is being tested?

The study tests VK2735 against a placebo to see if it's safe and effective for weight loss. Participants will be randomly assigned to receive either VK2735 or a placebo once weekly for 13 weeks while researchers track safety, how well it works, and how the body processes the drug.

What are the potential side effects?

While the side effects are not detailed here, common issues with medications like VK2735 may include digestive discomforts such as nausea or constipation, potential allergic reactions, headaches and possibly injection site reactions since it's administered weekly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with chronic pancreatitis.

Select...

I have been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent (relative) change from baseline to Week 13 in body weight

Secondary study objectives

Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13

Other study objectives

Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: VK2735 (Dose #4)Experimental Treatment1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group II: VK2735 (Dose #3)Experimental Treatment1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group III: VK2735 (Dose #2)Experimental Treatment1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group IV: VK2735 (Dose #1)Experimental Treatment1 Intervention

VK2735 is a peptide GLP-1 and GIP dual agonist

Group V: VK2735 (Placebo)Placebo Group1 Intervention

Placebo

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common weight loss treatments, such as GLP-1 receptor agonists like liraglutide and semaglutide, work by mimicking the incretin hormone GLP-1. This increases insulin secretion, decreases glucagon secretion, slows gastric emptying, and promotes satiety, thereby reducing appetite and caloric intake. These mechanisms are important for weight loss patients as they offer a comprehensive approach to managing weight by addressing both physiological and behavioral aspects of eating.

Modern obesity pharmacotherapy: weighing cardiovascular risk and benefit.Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?