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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07699380
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • AMX0035 — DRUG
    AMX0035 sachets
  • Placebo — DRUG
    Placebo sachets

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AMX0035
    Participants will be instructed to take one packet of AMX0035 daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \~6 months.
  • Placebo Comparator: Placebo
    Participants will be instructed to take one packet of placebo daily for the first 2 weeks, followed by 1 packet twice a day (morning and evening) thereafter for \~6 months.

Primary Outcome Measure

Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp [ Time Frame: Baseline, 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medicine Diabetes Institute (UWMDI)SeattleWashington98109
Amanda Bard, MMS, MS, CCRC
[email protected]
206-685-2069
Petter Bjornstad, MD (PRINCIPAL_INVESTIGATOR)

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University of Washington Medicine Diabetes Institute (UWMDI)· Seattle, WA

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