ECC4703 + Semaglutide for Obesity

Not currently recruiting at 14 trial locations
EC
Overseen ByEccogene Clinical Trials
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments, ECC4703 (an experimental treatment) and semaglutide, to evaluate their effectiveness in promoting weight loss and reducing liver fat. It includes two groups: one receiving ECC4703 with semaglutide and another receiving a placebo with semaglutide. Suitable participants are those with obesity (BMI of 30 or higher) who have not experienced significant weight changes in the past six months. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used GLP-1 agonists in the last 6 months or medications that cause significant weight gain in the last 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide is generally well-tolerated, with studies finding it safe and most side effects mild, such as nausea or diarrhea. Serious side effects are rare.

ECC4703 is newer, so less information is available. Early tests before human trials suggested it might aid weight loss when combined with semaglutide. Since this trial is in phase 2, ECC4703 has already passed some safety tests in earlier trials. Researchers are still learning about its effects in humans, focusing on its efficacy and safety for a larger group.12345

Why are researchers excited about this trial's treatments for obesity?

Researchers are excited about ECC4703 combined with semaglutide for treating obesity because it offers a potentially novel approach. ECC4703 is an experimental compound that, when paired with semaglutide—a medication already known for its effectiveness in weight loss—might enhance weight reduction more than current treatments alone. Unlike the standard of care, which typically involves GLP-1 receptor agonists like semaglutide by itself, this combination could act synergistically to improve outcomes by potentially targeting different pathways involved in obesity. This dual-action treatment might lead to more significant and faster weight loss, which is an exciting prospect for patients and healthcare providers alike.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare the combination of ECC4703 with semaglutide to a placebo with semaglutide. Research has shown that ECC4703 with semaglutide results in more weight loss than semaglutide alone. Early data indicate that this combination not only enhances weight loss but also targets fat reduction while preserving muscle mass. Studies have already proven that semaglutide alone is effective, leading to significant weight loss for many individuals. Adding ECC4703 appears to strengthen the weight loss effect, suggesting that ECC4703 could enhance the benefits of semaglutide for those aiming to lose weight.36789

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI of 30 or higher) who have had a stable weight for the past 6 months, healthy kidney function, normal blood sugar levels (HbA1c ≤6.5%), and are able to follow study procedures and contraception guidelines.

Inclusion Criteria

4. HbA1c ≤6.5%.
5. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 (per CKD-EPI 2021 formula).
1. Capable of providing written informed consent and complying with all trial procedures.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ECC4703 or placebo orally daily and semaglutide subcutaneously once weekly

20 weeks
Weekly visits for semaglutide administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ECC4703
  • Semaglutide

Trial Overview

The study compares an oral drug called ECC4703, semaglutide, and a placebo to see which helps most with weight loss over about 20 weeks. Some participants will also have their liver fat measured using MRI scans.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: ECC4703 + semaglutideExperimental Treatment2 Interventions
Group II: Arm 2: Placebo + semaglutidePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eccogene

Lead Sponsor

Trials
5
Recruited
300+

Citations

Eccogene to Report Preclinical Data with ECC4703, ...

The combination therapy of ECC4703 and semaglutide or tirzepatide resulted in significantly greater weight loss compared to semaglutide or tirzepatide alone.

2183-LB: Metabolic Effects of ECC4703, a Liver Targeting ...

Results: The combination therapy of ECC4703 and semaglutide or tirzepatide resulted in significantly greater weight loss compared to semaglutide or ...

Efficacy of Semaglutide in Treating Obesity - PMC - NIH

In the study participants receiving semaglutide 0.5 mg, 1 mg and placebo, >5% reduction of body weight was noted in 42%, 66%, and 11% respectively at the end of ...

Eccogene's ECC-4703 leads to greater weight loss in ...

The results showed that the combination of ECC-4703 plus semaglutide or tirzepatide resulted in significantly greater weight loss compared to single agents ...

Eccogene Announces First Patient Enrolled in MIST Phase ...

Our preclinical data suggest ECC4703 may contribute to deeper weight reduction driven primarily by fat mass loss over lean mass loss, and, to ...

Safety profile of semaglutide versus placebo in the SELECT ...

The objective of this study was to assess safety of once‐weekly subcutaneous semaglutide 2.4 mg versus placebo, beyond reduction in major adverse ...

ECC4703 + Semaglutide for Obesity · Info for Participants

The primary objective of this trial is to evaluate the effect of oral ECC4703 on body weight reduction and in a sub-study on liver fat ...

Eccogene to Report Preclinical Data with ECC4703, ...

The combination therapy of ECC4703 and semaglutide or tirzepatide resulted in significantly greater weight loss compared to semaglutide or ...

Eccogene Announces First Patient Enrolled in MIST Phase ...

Eccogene Announces First Patient Enrolled in MIST Phase 2a Trial Evaluating ECC4703 as an Adjunct to Semaglutide for the Treatment of Obesity.