Phase 2RecruitingNCT07699380

MetMod-T1D: AMX0035 and insulin sensitivity

What this study tests

A phase 2 randomized placebo-controlled trial of AMX0035 (sodium phenylbutyrate plus taurursodiol), added to insulin in adults with T1D. It tests whole-body insulin sensitivity over 24 weeks.

Editorial review: 2026-09-16. What was checked and what remains uncertain.

Registry checked: 2026-09-16. Registry’s own update: 2026-09-15.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews.

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?: Adults aged 18–69 with T1D for at least a year, using insulin, with HbA1c below 9.5% and BMI 18.5–40 kg/m². The September registry lists a recruiting Seattle site and an Amsterdam site not yet recruiting. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results: No results posted. The registry targets 60 participants with estimated completion in December 2029. Its clamp measure of insulin sensitivity does not by itself establish preservation of beta cells, insulin independence or long-term benefit.Read the result sources and their limitations →
Important harms: Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval: Study regions: United States, European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?: Read this trial’s review notes for the checks completed and what remains unresolved. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp — Baseline, 24 weeks

The full picture

What the study asks

A phase 2 randomized placebo-controlled trial of AMX0035 (sodium phenylbutyrate plus taurursodiol), added to insulin in adults with T1D. It tests whole-body insulin sensitivity over 24 weeks.

Who it involves

Adults aged 18–69 with T1D for at least a year, using insulin, with HbA1c below 9.5% and BMI 18.5–40 kg/m². The September registry lists a recruiting Seattle site and an Amsterdam site not yet recruiting. This is a summary; the full registry lists additional criteria.¹

Design and timing

The registry lists 60 participants (estimated enrollment). Primary completion: 2029-12 (estimated). Study completion: 2029-12 (estimated). Estimated dates can change and do not mean results are available.¹

Evidence and limits

No results posted. The registry targets 60 participants with estimated completion in December 2029. Its clamp measure of insulin sensitivity does not by itself establish preservation of beta cells, insulin independence or long-term benefit.

ClinicalTrials.gov. NCT07699380. Record checked 16 September 2026; last update posted 2026-09-15. https://clinicaltrials.gov/study/NCT07699380 ↩ ↩²

Sources

[1]METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D) (NCT07699380) · registry — Protocol and current registry status checked 16 September 2026.