MedTrace Logo

METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)

NCT07699380 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-13

No results posted yet for this study

Summary

The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center/Diabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.

Conditions

  • Type 1 Diabetes (T1D)
  • Metabolic Diseases
  • Glucose Metabolism Disorders
  • Endocrine System Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Diabetes Melletus, Type 1
  • Nutritional and Metabolic Diseases
  • Combination Therapy

Interventions

DRUG

AMX0035

AMX0035 sachets

DRUG

Placebo

Placebo sachets

Sponsors & Collaborators

Principal Investigators

  • Petter M Bjornstad, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699380 on ClinicalTrials.gov