A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of ECC4703 as an Adjunct to Semaglutide in Adults With Obesity
Eccogene
Summary
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 content as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 20.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Capable of providing written informed consent and complying with all trial procedures. 2. Willing to comply with contraception requirements (as applicable to males and females of childbearing potential). 3. Obese with BMI ≥30 kg/m\^2 and stable body weight within 6 months prior to screening. 4. HbA1c ≤6.5%. 5. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 (per CKD-EPI 2021 formula). 6. If participant consents to enter the imaging substudy, has liver fat content by MRI-PDFF \>8% at baseline (Week 9). Exclusion Criteria: 1. History or current diagnosi…
Interventions
- DrugECC4703
orally QD
- DrugPlacebo
orally QD
- DrugSemaglutide
SC once weekly
Locations (15)
- Central Research Associates - Flourish - PPDSBirmingham, Alabama
- Anaheim Clinical Trials LLC - Anaheim - CenExel - PPDSAnaheim, California
- Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDSLos Alamitos, California
- AES - DRS - Optimal Research Florida - MelbourneMelbourne, Florida
- ForCare Clinical Research - CenExel FCR - PPDSTampa, Florida
- Atlanta Center for Medical Research - CenExel ACMR - PPDSAtlanta, Georgia