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Adult ObesityPhase 2NCT07505303

MIST (Metabolic Intervention With Semaglutide and THR-β Therapy) Trial

A Phase 2 study testing ECC4703 and Semaglutide in people with Adult Obesity and Weight Management, run by Eccogene at 15 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Adult Obesity, Weight Management
What is being tested?
ECC4703 and Semaglutide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
15 sitesUnited States
Study dates
23 Mar 2026to 15 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Anaheim Clinical Trials LLC - Anaheim - CenExel - PPDS

    Anaheim, California, 92081

  • Atlanta Center for Medical Research - CenExel ACMR - PPDS

    Atlanta, Georgia, 30331

  • Central Research Associates - Flourish - PPDS

    Birmingham, Alabama, 35205

  • Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS

    Cincinnati, Ohio, 45246

  • Velocity Clinical Research - Dallas - PPDS

    Dallas, Texas, 75230

  • iResearch Atlanta - CenExel - PPDS

    Decatur, Georgia, 30030

  • Velocity Clinical Research - Durham - PPDS

    Durham, North Carolina, 27701

  • Velocity Clinical Research - Providence - PPDS

    East Greenwich, Rhode Island, 02818

  • Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS

    Los Alamitos, California, 90720

  • AES - DRS - Optimal Research Florida - Melbourne

    Melbourne, Florida, 32934

  • Velocity Clinical Research (3345 N 107th St) - Omaha - Nebraska - PPDS

    Omaha, Nebraska, 68134

  • AES - DRS - Synexus Clinical Research US, Inc. - Richfield - Minneapolis

    Richfield, Minnesota, 55423

  • AES - DRS - Synexus Clinical Research US, Inc. - San Antonio

    San Antonio, Texas, 78229

  • Flourish Research - San Antonio - PPDS

    San Antonio, Texas, 78229

  • ForCare Clinical Research - CenExel FCR - PPDS

    Tampa, Florida, 33613

Other trials in United States

About this study

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

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.

Being tested
ECC4703, Placebo, Semaglutide
Keywords
Obesity, GLP-1, Weight Management, Semaglutide, MIST, ECC4703, THR-β
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECC4703Drug

    orally QD

  • PlaceboDrug

    orally QD

  • SemaglutideDrug

    SC once weekly

Study groups in NCT07505303
Study groupRoleWhat they receive
Arm 1: ECC4703 + semaglutideExperimentalECC4703 orally QD + semaglutide SC once weekly
Receives: Drug: ECC4703; Drug: Semaglutide
Arm 2: Placebo + semaglutidePlacebo comparatorPlacebo orally QD + semaglutide SC once weekly
Receives: Drug: Placebo; Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Body Weight from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  2. Proportion of Participants Achieving ≥5% Reduction in Body Weight from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  3. Absolute Change in Liver Fat Content as Measured by MRI-PDFF in Participants With Hepatic Steatosis

    Measured: Baseline (Week 9) to Week 20

  4. Percentage Change in Liver Fat Content as Measured by MRI-PDFF in Participants With Hepatic Steatosis

    Measured: Baseline (Week 9) to Week 20

  5. Proportion of Participants With ≥30% Relative Reduction in Liver Fat Content as Measured by MRI-PDFF

    Measured: Baseline (Week 9) to Week 20

Secondary outcomes (17)

  1. Change in Percentage Lean Mass as Measured by DXA

    Measured: Baseline (Week 9) to Week 20

  2. Change in Percentage Total Body Fat Mass as Measured by DXA

    Measured: Baseline (Week 9) to Week 20

  3. Change in Percentage Visceral Fat Mass as Measured by DXA

    Measured: Baseline (Week 9) to Week 20

  4. 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

    Measured: Baseline (Week 9) to Week 20

  5. Change in Lipid Parameters from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  6. Change in Body Weight (kg) from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  7. Proportion of Participants Achieving ≥2% and ≥3% Reduction in Body Weight from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  8. Change in Alanine Aminotransferase (ALT) Levels from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  9. Change in Aspartate Aminotransferase (AST) Levels from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  10. Change in Alkaline Phosphatase (ALP) Levels from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  11. Change in Gamma-Glutamyl Transferase (GGT) Levels from Baseline (Week 9) to Week 20

    Measured: Baseline (Week 9) to Week 20

  12. Frequency of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: From first dose through Week 20 (or end of study visit)

  13. Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: From first dose through Week 20 (or end of study visit)

  14. Laboratory Safety Evaluations

    changes in clinical laboratory parameters, including hematology, serum chemistry, and urinalysis.

    Measured: Baseline through Week 20

  15. Changes in 12-Lead Electrocardiogram (ECG) Parameters

    Change in QT Interval, etc

    Measured: Baseline through Week 20

  16. Changes in Vital Signs Findings

    including blood pressure, etc

    Measured: Baseline through Week 20

  17. Changes in Physical Examination Findings

    including blood pressure, etc

    Measured: Baseline through Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start23 Mar 2026
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07505303
Sponsor's protocol ID
EC0011
Status last verified
Jun 2026
First submitted
5 Mar 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ECC4703 and Semaglutide in people with Adult Obesity and Weight Management, run by Eccogene at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Body Weight from Baseline (Week 9) to Week 20 (time frame: Baseline (Week 9) to Week 20). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07505303.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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