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

Korábbi kezelés

• Use of weight-loss medications/programs
• Use of prohibited medications (including GLP-1 therapies, immunosuppressants, chronic anti-inflammatory drugs, or moderate or strong CYP3A4 modulators)
• 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

Más betegség

• Type 1 diabetes,
• Uncontrolled Type 2 diabetes,
• Uncontrolled hypertension and /or hyperlipidemia
• 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

Egyéb

• Recent weight change of 5% or more,
• Contraindications to MRI
• Women who are pregnant or nursing

• 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