Adult Obesity, Weight Management
Conditions
Keywords
Obesity, GLP-1, Weight Management, Semaglutide, MIST, ECC4703, THR-β
Brief 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.
Interventions
Sponsors
Eccogene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 diagnosis of type 1 or type 2 diabetes mellitus. 2. Weight change \>5% of total body weight within 6 months prior to screening or planned initiation of a weight loss program or use of weight-altering medication. 3. Obesity induced by endocrine disorders such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome. 4. Use of GLP-1 agonist treatment within the last 6 months prior to screening. 5. History or current evidence of a pituitary disorder. 6. Have current treatment with or history (within 3 months prior to screening) of treatment with medications that may cause significant weight gain. 7. ALT or AST \>1.5×ULN, or ALP \>1.5×ULN at screening. 8. Documented evidence or clinical signs/symptoms of advanced liver disease including liver cirrhosis, portal hypertension, or hepatic decompensation. 9. History of significant alcohol consumption for \>3 consecutive months within a year prior to screening. 10. Current or past therapy with THR-β agonists (eg, resmetirom). 11. Active untreated hyperthyroidism or hyperthyroidism currently treated with antithyroid medications including methimazole or propylthiouracil. 12. Clinically significant thyroid dysfunction including uncontrolled hypothyroidism or hyperthyroidism. 13. History of bariatric surgery, fitting of a weight loss device, or intestinal bypass surgery within 5 years prior to screening. 14. History of major surgery within 8 weeks prior to screening. 15. Clinically relevant acute or chronic medical condition or unstable disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change in Body Weight from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Proportion of Participants Achieving ≥5% Reduction in Body Weight from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Absolute Change in Liver Fat Content as Measured by MRI-PDFF in Participants With Hepatic Steatosis | Baseline (Week 9) to Week 20 |
| Percentage Change in Liver Fat Content as Measured by MRI-PDFF in Participants With Hepatic Steatosis | Baseline (Week 9) to Week 20 |
| Proportion of Participants With ≥30% Relative Reduction in Liver Fat Content as Measured by MRI-PDFF | Baseline (Week 9) to Week 20 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage Lean Mass as Measured by DXA | Baseline (Week 9) to Week 20 | — |
| Change in Percentage Total Body Fat Mass as Measured by DXA | Baseline (Week 9) to Week 20 | — |
| Change in Percentage Visceral Fat Mass as Measured by DXA | Baseline (Week 9) to Week 20 | — |
| Change in Glycemic Parameters from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | Change in HbA1c and fasting plasma glucose levels from baseline (Week 9) to Week 20 |
| Change in Lipid Parameters from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Change in Body Weight (kg) from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Proportion of Participants Achieving ≥2% and ≥3% Reduction in Body Weight from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Change in Alanine Aminotransferase (ALT) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Change in Aspartate Aminotransferase (AST) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Change in Alkaline Phosphatase (ALP) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Change in Gamma-Glutamyl Transferase (GGT) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | — |
| Frequency of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose through Week 20 (or end of study visit) | — |
| Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose through Week 20 (or end of study visit) | — |
| Laboratory Safety Evaluations | Baseline through Week 20 | changes in clinical laboratory parameters, including hematology, serum chemistry, and urinalysis. |
| Changes in 12-Lead Electrocardiogram (ECG) Parameters | Baseline through Week 20 | Change in QT Interval, etc |
| Changes in Vital Signs Findings | Baseline through Week 20 | including blood pressure, etc |
| Changes in Physical Examination Findings | Baseline through Week 20 | including blood pressure, etc |
Countries
United States
Outcome results
None listed