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Recruiting NCT07656727

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

Phase II Interventional Obesity and Cardiovascular Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral BGE-102, Oral Placebo Matching BGE-102.
Who it may be relevant to
Registry conditions: Obesity and Cardiovascular Risk. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Randomized, Double-Blind, Dose-Range, Placebo-Controlled, 12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors

Overview

The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.

Detailed description

The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment.

Study details include:

* The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks). * The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16. * The treatment duration will be up to 12 weeks. BGE-102 will be given as Dose A, Dose B or Dose C QD capsules or placebo QD capsules for the entire 12-week treatment period.

Interventions

  • Drug Oral BGE-102
    Capsules
  • Drug Oral Placebo Matching BGE-102
    Capsules

Primary outcome measures

  • Percent change in hsCRP (Dose A) [Time frame: Week 12]
  • Percent change in hsCRP (Dose B) [Time frame: Week 12]
  • Percent change in hsCRP (Dose C) [Time frame: Week 12]
Secondary outcome measures (2)
  • Incidence of serious adverse events (SAEs) [Time frame: Up to Week 16]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to Week 16]

Eligibility criteria

Inclusion criteria

  • Obese Male and Female adults with BMI 32-42 kg/m²
  • Elevated blood test for hsCRP consistent with chronic systemic inflammation
  • At least one cardiovascular risk factor or metabolic syndrome feature
  • Stable background therapies and willing to maintain stable diet/exercise habits during the study

Exclusion criteria

  • Type 1 diabetes,
  • Uncontrolled Type 2 diabetes,
  • Uncontrolled hypertension and /or hyperlipidemia
  • Recent weight change of 5% or more,
  • Use of weight-loss medications/programs
  • Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
  • Clinically significant ECG abnormalities or arrhythmias
  • Use of prohibited medications (including GLP-1 therapies, immunosuppressants, chronic anti-inflammatory drugs, or moderate or strong CYP3A4 modulators)
  • Contraindications to MRI
  • Clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass \[bariatric\] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity
  • Women who are pregnant or nursing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Site 108 — Chandler
  • Site 115 — Peoria
  • Site 110 — Tucson
  • Site 100 — Rogers
  • Site 109 — Maitland
  • Site 102 — Miami
  • Site 104 — Port Orange
  • Site 103 — Lexington
  • … and 4 more centers
Puerto Rico · 1 center
  • Site 105 — San Juan

Identifiers

NCT: NCT07656727 · BGE-102-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗