BGE-102 for Obesity and Cardiovascular Risk

(QUELL-CV Trial)

Not currently recruiting at 16 trial locations
CR
Overseen ByCentral Recruiting
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 BGE-102, an experimental drug that might help people with obesity by reducing inflammation, potentially lowering cardiovascular risks. Researchers aim to assess how BGE-102 affects specific blood markers related to inflammation. Participants will receive one of three doses of BGE-102 or a placebo (a pill with no active medicine) to evaluate the drug's safety and tolerability. The trial seeks adults who are obese, have a consistent inflammation marker in their blood, and at least one heart risk factor, but who have not recently lost significant weight or used weight-loss programs. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that BGE-102 is likely to be safe for humans?

Research has shown that BGE-102 was well tolerated in previous studies. In earlier trials, participants did not encounter major safety issues. Reports indicated that BGE-102 maintained a good safety record, as it did not cause serious side effects for most participants. These findings suggest that BGE-102 might be safe for treating obesity and reducing heart disease risk. Prospective clinical trial participants may find reassurance in the treatment's safety based on past research.12345

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity and cardiovascular risk, which often include lifestyle changes, appetite suppressants, or medications like orlistat and phentermine, BGE-102 offers a fresh approach. Researchers are intrigued by BGE-102 because it is designed to be taken as a simple daily capsule, potentially making it easier for patients to adhere to their treatment regimen. Additionally, while many current drugs focus on reducing appetite or blocking fat absorption, BGE-102 may target different biochemical pathways involved in metabolism and fat storage, offering a novel mechanism of action. This unique approach could provide a new way to manage these conditions more effectively.

What evidence suggests that BGE-102 might be an effective treatment for obesity and cardiovascular risk?

Studies have shown that BGE-102 can greatly reduce inflammation. In earlier research, individuals with obesity who took BGE-102 experienced an 86% average drop in hsCRP, a marker of inflammation. This is significant because high inflammation is associated with obesity and heart problems. The treatment blocks NLRP3, a protein that contributes to inflammation. These promising results suggest that BGE-102 could improve health for those with obesity and heart-related risk factors. Participants in this trial will receive varying doses of BGE-102 to further evaluate its effectiveness and safety.23467

Are You a Good Fit for This Trial?

This trial is for adults with obesity and risk factors for heart disease who are otherwise healthy. People with serious health conditions or those not meeting specific study requirements cannot participate.

Inclusion Criteria

Elevated blood test for hsCRP consistent with chronic systemic inflammation
At least one cardiovascular risk factor or metabolic syndrome feature
I am an adult with a BMI between 32 and 42.
See 1 more

Exclusion Criteria

My Type 2 diabetes is not well controlled.
Recent weight change of 5% or more
Clinically significant ECG abnormalities or arrhythmias
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive BGE-102 or placebo once daily for 12 weeks to evaluate pharmacodynamics, safety, and tolerability

12 weeks
Visits every 2 weeks for the first 4 weeks, then every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BGE-102

Trial Overview

The study tests an oral drug called BGE-102 against a placebo to see how it affects inflammation markers in the blood, as well as its safety and tolerability. Participants are randomly assigned to receive either BGE-102 or a placebo.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm C: BGE-102 Dose CExperimental Treatment1 Intervention
Group II: Arm B: BGE-102 Dose BExperimental Treatment1 Intervention
Group III: Arm A: BGE-102 Dose AExperimental Treatment1 Intervention
Group IV: Arm D: Dose DPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioAge Labs, Inc.

Lead Sponsor

Trials
5
Recruited
410+

Citations

BioAge Reports Positive Phase 1 Data for BGE-102, a Novel ...

120 mg and newly announced 60 mg once-daily doses each achieved ≥85% median hsCRP reductions in participants with obesity and elevated ...

NCT07656727 | A Phase 2 Study to Evaluate the ...

BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo.

BioAge Labs Advances BGE-102 NLRP3 Inhibitor With ...

BioAge Labs advances BGE-102 NLRP3 inhibitor into Phase 2 cardiovascular trial after Phase 1 showed 86% median hsCRP reduction.

BGE-102 / BioAge Labs

A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors

BGE-102 Phase 1 Data Show Promising Results for ...

In participants with obesity and elevated hsCRP: • 86% median hsCRP reduction at both once-daily doses … 86% median hsCRP reduction at both ...

BioAge Announces Additional Positive Interim Phase 1 Data ...

BGE-102 was well tolerated with a favorable safety profile Patent issued covering additional composition of matter and novel NLRP3 binding site ...

BGE-102 - Drug Targets, Indications, Patents

12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors