VTX3232 + Semaglutide for Obesity

Recruiting at 13 trial locations

Overseen By Zomagen Clinical Trial Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zomagen Biosciences Ltd.

Must not be taking: GLP-1 agonists, Anti-inflammatories

Disqualifiers: Diabetes, Gastric issues, Weight loss programs, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

176 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 3 10 11}

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

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

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

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

Group I: VTX3232 Dose A in combination with semaglutide Experimental Treatment 1 Intervention

VTX3232 Dose A in combination with semaglutide

Group II: VTX3232 Dose A Experimental Treatment 1 Intervention

VTX3232 Dose A

Group III: Placebo in combination with semaglutide Experimental Treatment 1 Intervention

Placebo in combination with semaglutide

Group IV: Placebo Placebo Group 1 Intervention

Placebo

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study involving adults with overweight or obesity demonstrated that once-weekly semaglutide significantly reduced body weight compared to a placebo, indicating its efficacy as a weight management treatment.

The results suggest that semaglutide not only aids in weight loss but also has a favorable safety profile, making it a promising option for individuals struggling with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In overweight or obese adults without diabetes, semaglutide increased weight loss and GI disorders. Rajagopal, S., Cheskin, LJ.[2022]

In a study of 129 patients with severe obesity (BMI ≥ 40 kg/m²), semaglutide 2.4 mg treatment led to a significant average weight loss of 9.1% over 24 weeks, showing its effectiveness in this population.

There was no significant difference in weight loss between patients who had previously undergone bariatric surgery and those who had not, indicating that semaglutide can be a viable treatment option for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. Bonnet, JB., Tournayre, S., Anitcheou, J., et al.[2023]

Long-acting GLP-1 receptor agonists, such as liraglutide and semaglutide, are effective anti-obesity medications that can lead to significant weight loss, with semaglutide showing an average weight loss of 11.6% after one year, compared to 5.5% with liraglutide.

Both medications are generally well tolerated, with similar safety profiles, though they can cause transient gastrointestinal issues; ongoing long-term studies are needed to further evaluate their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. Christensen, RM., Juhl, CR., Torekov, SS.[2020]

In a study involving 2117 participants treated with semaglutide 2.4 mg for 68 weeks, gastrointestinal adverse events (AEs) like nausea and diarrhea were more common than in the placebo group, but these AEs were mostly mild and transient, with only 4.3% of participants discontinuing treatment due to them.

Weight loss with semaglutide was significant and similar in participants with and without GI AEs, indicating that the weight loss effects of semaglutide are largely independent of these gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wharton, S., Calanna, S., Davies, M., et al.[2022]

Subcutaneous semaglutide (Wegovy) has been shown to significantly reduce body weight in overweight and obese individuals, with a dose-dependent effect observed in four Phase 3 trials involving 5000 participants.

While semaglutide resulted in greater weight loss compared to placebo, gastrointestinal side effects were the most common safety concerns, highlighting the need for further studies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. Phillips, A., Clements, JN.[2022]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Knop, FK., Aroda, VR., do Vale, RD., et al.[2023]

In a cohort study of 408 adults with obesity, those treated with weekly semaglutide injections (1.7 mg or 2.4 mg) experienced significant weight loss, averaging 5.9% after 3 months and 10.9% after 6 months, which aligns with results from randomized clinical trials.

The majority of patients (87.3%) achieved at least 5% weight loss after 6 months, although those with type 2 diabetes experienced less weight loss compared to those without diabetes, indicating that diabetes status may influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. Ghusn, W., De la Rosa, A., Sacoto, D., et al.[2022]

In a 20-week trial with 72 adults, once-weekly subcutaneous semaglutide 2.4 mg significantly reduced appetite and energy intake, leading to a 9.9% reduction in body weight compared to only 0.4% with placebo.

Semaglutide improved participants' control over eating and reduced food cravings without causing delayed gastric emptying, indicating its efficacy in managing obesity without adverse effects on gastric function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Friedrichsen, M., Breitschaft, A., Tadayon, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg according to antidepressant use at baseline: A post hoc subgroup analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In overweight or obese adults without diabetes, semaglutide increased weight loss and GI disorders. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. [2020]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Weight Loss Outcomes Associated With Semaglutide Treatment for Patients With Overweight or Obesity. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. [2021]