176 Participants Needed

VTX3232 + Semaglutide for Obesity

Recruiting at 13 trial locations
ZC
Overseen ByZomagen Clinical Trial Contact
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. You must not use any weight loss medications, supplements, or over-the-counter products within 6 months before or during the study, unless they are part of the study treatment. Additionally, you must stop using immunosuppressive biologics, anti-inflammatory medications, colchicine, and glucose-lowering agents for specific periods before starting the trial.

What data supports the effectiveness of the drug Semaglutide for obesity?

Semaglutide has been shown to help people lose about 15% of their initial weight over 68 weeks, making it one of the most effective obesity medications available. It also improves heart health and physical functioning, providing more options for managing weight.12345

Is the combination of VTX3232 and Semaglutide safe for treating obesity?

Semaglutide, used for obesity, is generally well tolerated with the most common side effects being temporary stomach issues like nausea. Long-term studies have not shown new safety concerns, but ongoing monitoring is important to fully understand its safety.16789

What makes the drug VTX3232 + Semaglutide unique for treating obesity?

The combination of VTX3232 with semaglutide is unique because semaglutide, a glucagon-like peptide-1 receptor agonist, has shown significant weight loss results, reducing initial weight by about 15% over 68 weeks, and improving cardiovascular risk factors. This combination may offer enhanced benefits compared to semaglutide alone, although specific details about VTX3232's role are not provided.1231011

What is the purpose of this trial?

This is a study to understand if taking VTX3232 alone or in combination with semaglutide is safe in participants diagnosed with Obesity. Approximately 160 patients will take VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide.This study consists of a 30-day Screening Period (to see if a participant qualifies for a study), a 12-week double-blind treatment period (a participant receives VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide), and a 30-day Follow-Up Period. The maximum duration of treatment will be approximately 12 weeks.

Research Team

SN

Snehal Naik, PhD

Principal Investigator

Zomagen Biosciences Ltd.

Eligibility Criteria

This trial is for individuals with obesity who qualify after a 30-day screening. Participants will be randomly assigned to receive either VTX3232 alone, a placebo, VTX3232 with semaglutide, or placebo with semaglutide over a 12-week period followed by a 30-day follow-up.

Inclusion Criteria

BMI ≥ 30.0 to ≤ 42.0 kg/m2 at screening
Stable body weight (± 5%) for at least 3 months prior to screening
hs-CRP ≥ 2 mg/L at screening
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Exclusion Criteria

I haven't used weight loss drugs or supplements in the last 6 months.
I have a significant stomach emptying issue, have had weight loss surgery, or treatments for obesity.
Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Semaglutide
  • VTX3232
Trial Overview The study aims to test the safety and effectiveness of VTX3232 both alone and in combination with semaglutide in treating obesity. It's designed as double-blind, meaning neither the participants nor the researchers know who receives which treatment until after the study.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: VTX3232 Dose A in combination with semaglutideExperimental Treatment1 Intervention
VTX3232 Dose A in combination with semaglutide
Group II: VTX3232 Dose AExperimental Treatment1 Intervention
VTX3232 Dose A
Group III: Placebo in combination with semaglutideExperimental Treatment1 Intervention
Placebo in combination with semaglutide
Group IV: PlaceboPlacebo Group1 Intervention
Placebo

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Who Is Running the Clinical Trial?

Zomagen Biosciences Ltd.

Lead Sponsor

Trials
4
Recruited
210+

Findings from Research

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.
In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.
Semaglutide for the treatment of obesity.Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]
In a study involving participants with a BMI of 27 kg/m² or higher, semaglutide led to significant weight loss of -16.2% for those with a BMI <35 and -14.0% for those with a BMI ≥35 after 68 weeks, both significantly better than placebo.
Semaglutide also positively impacted cardiometabolic risk factors across all subgroups, including those with obesity-related comorbidities like prediabetes and high cardiovascular disease risk.
Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial.McGowan, BM., Houshmand-Oeregaard, A., Laursen, PN., et al.[2023]
Semaglutide 2.4 mg led to significant weight loss in adults with overweight/obesity, achieving a mean change of -15.7% for those on antidepressants compared to -0.2% for placebo, demonstrating its efficacy regardless of antidepressant use.
The safety profile of semaglutide was consistent with previous studies, showing a similar prevalence of adverse events between the semaglutide and placebo groups among participants taking antidepressants.
Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis.Kushner, RF., Fink-Jensen, A., Frenkel, O., et al.[2023]

References

Semaglutide for the treatment of obesity. [2023]
Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. [2023]
Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis. [2023]
In overweight or obese adults without diabetes, semaglutide increased weight loss and GI disorders. [2022]
Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. [2023]
Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. [2020]
Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. [2022]
Clinical review of subcutaneous semaglutide for obesity. [2022]
Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. [2022]
The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. [2021]
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