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Clinical Trial NCT07505303 for Adult Obesity, Weight Management is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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MIST (Metabolic Intervention With Semaglutide and THR-β Therapy) Trial Phase 2 160
Clinical Trial NCT07505303 is designed to study Treatment for Adult Obesity, Weight Management. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on March 13, 2026 until the study accrues 160 participants. Led by Eccogene, this study is expected to complete by November 20, 2026. The latest data from ClinicalTrials.gov was last updated on April 1, 2026.
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.
Official Title
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
Conditions
Adult ObesityWeight ManagementOther Study IDs
- EC0011
NCT ID Number
Start Date (Actual)
2026-03-13
Last Update Posted
2026-04-01
Completion Date (Estimated)
2026-11-20
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Obesity
GLP-1
Weight Management
Semaglutide
MIST
ECC4703
THR-β
GLP-1
Weight Management
Semaglutide
MIST
ECC4703
THR-β
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 1: ECC4703 + semaglutide ECC4703 orally QD + semaglutide SC once weekly | ECC4703 orally QD Semaglutide SC once weekly |
Placebo ComparatorArm 2: Placebo + semaglutide Placebo orally QD + semaglutide SC once weekly | Placebo orally QD Semaglutide SC once weekly |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | Change in HbA1c and fasting plasma glucose levels from baseline (Week 9) to Week 20 | 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 | changes in clinical laboratory parameters, including hematology, serum chemistry, and urinalysis. | Baseline through Week 20 |
Changes in 12-Lead Electrocardiogram (ECG) Parameters | Change in QT Interval, etc | Baseline through Week 20 |
Changes in Vital Signs Findings | including blood pressure, etc | Baseline through Week 20 |
Changes in Physical Examination Findings | including blood pressure, etc | Baseline through Week 20 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Capable of providing written informed consent and complying with all trial procedures.
- Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).
- Obese with BMI ≥30 kg/m^2 and stable body weight within 6 months prior to screening.
- HbA1c ≤6.5%.
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m^2 (per CKD-EPI 2021 formula).
- If participant consents to enter the imaging substudy, has liver fat content by MRI-PDFF >8% at baseline (Week 9).
- History or current diagnosis of type 1 or type 2 diabetes mellitus.
- 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.
- Obesity induced by endocrine disorders such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
- Use of GLP-1 agonist treatment within the last 6 months prior to screening.
- History or current evidence of a pituitary disorder.
- Have current treatment with or history (within 3 months prior to screening) of treatment with medications that may cause significant weight gain.
- ALT or AST >1.5×ULN, or ALP >1.5×ULN at screening.
- Documented evidence or clinical signs/symptoms of advanced liver disease including liver cirrhosis, portal hypertension, or hepatic decompensation.
- History of significant alcohol consumption for >3 consecutive months within a year prior to screening.
- Current or past therapy with THR-β agonists (eg, resmetirom).
- Active untreated hyperthyroidism or hyperthyroidism currently treated with antithyroid medications including methimazole or propylthiouracil.
- Clinically significant thyroid dysfunction including uncontrolled hypothyroidism or hyperthyroidism.
- History of bariatric surgery, fitting of a weight loss device, or intestinal bypass surgery within 5 years prior to screening.
- History of major surgery within 8 weeks prior to screening.
- Clinically relevant acute or chronic medical condition or unstable disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic system.
EccogeneStudy Central Contact
Contact: Eccogene Clinical Trials, +1-617-807-4087, [email protected]
15 Study Locations in 1 Countries
Alabama
Central Research Associates - Flourish - PPDS, Birmingham, Alabama, 35205, United States
California
Anaheim Clinical Trials LLC - Anaheim - CenExel - PPDS, Anaheim, California, 92081, United States
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS, Los Alamitos, California, 90720, United States
Florida
AES - DRS - Optimal Research Florida - Melbourne, Melbourne, Florida, 32934, United States
ForCare Clinical Research - CenExel FCR - PPDS, Tampa, Florida, 33613, United States
Georgia
Atlanta Center for Medical Research - CenExel ACMR - PPDS, Atlanta, Georgia, 30331, United States
iResearch Atlanta - CenExel - PPDS, Decatur, Georgia, 30030, United States
Minnesota
AES - DRS - Synexus Clinical Research US, Inc. - Richfield - Minneapolis, Richfield, Minnesota, 55423, United States
Nebraska
Velocity Clinical Research (3345 N 107th St) - Omaha - Nebraska - PPDS, Omaha, Nebraska, 68134, United States
North Carolina
Velocity Clinical Research - Durham - PPDS, Durham, North Carolina, 27701, United States
Ohio
Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS, Cincinnati, Ohio, 45246, United States
Rhode Island
Velocity Clinical Research - Providence - PPDS, East Greenwich, Rhode Island, 02818, United States
Texas
Velocity Clinical Research - Dallas - PPDS, Dallas, Texas, 75230, United States
AES - DRS - Synexus Clinical Research US, Inc. - San Antonio, San Antonio, Texas, 78229, United States
Flourish Research - San Antonio - PPDS, San Antonio, Texas, 78229, United States