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

NCT07699380 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MetMod-T1D-AMX0035
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp

  Evaluate the effect of 24 weeks of AMX0035 versus placebo on whole-body insulin sensitivity in T1D as assessed by gold-standard two-stage hyperinsulinemic-euglycemic clamp. * Two-stage hyperinsulinemic-euglycemic clamp studies will occur at baseline and 24 weeks. * Insulin sensitivity will be quantified using the M-value (glucose infusion rate), normalized to lean body mass measured by dual-energy X-ray absorptiometry (DXA) and insulin concentration.

  Baseline, 24 weeks

Secondary Outcomes (5)

• Changes in glycemic control

  Baseline, 24 weeks

• Changes in body composition

  Baseline, 24 weeks

• Changes in immune and metabolic biomarkers

  Baseline, 24 weeks

• Changes in mitochondrial function

  Baseline, 24 weeks

• Establish the safety and tolerability of AMX0035 in adults with T1D

  Duration of study

Study Arms (2)

AMX0035

EXPERIMENTAL

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.

Drug: AMX0035

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

AMX0035 DRUG

AMX0035 sachets

AMX0035

Placebo DRUG

Placebo sachets

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year)
• Currently on insulin therapy (multiple daily injections or insulin pump)
• HbA1c \<9.5%
• BMI 18.5-40 kg/m2
• On stable dose of RASB or statin, if indicated
• Willing and able to comply with all study procedures

You may not qualify if:

• History of pancreatic disease (including pancreatitis) or pancreatic surgery
• History of cardiovascular disease or stroke within the past 6 months
• History of heart failure per New York Heart Association criteria
• History of severe edema or salt restriction requirement
• Biliary disease or pathologies that may alter enterohepatic circulation of bile acids
• Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m²
• Liver disease (ALT/AST \>3x upper limit of normal \[ULN\])
• Pregnancy, breastfeeding, or planning pregnancy during the study period
• Known hypersensitivity to study drug components
• Abnormal baseline ECG
• Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)
• Chronic use of anticoagulants
• Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3
• Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein
• History of severe hypoglycemia requiring assistance within the past 3 months

Sponsors & Collaborators

• University of Washington: lead
• Breakthrough T1D: collaborator

Study Sites (2)

University of Washington Medicine Diabetes Institute (UWMDI)

Seattle, Washington, 98109, United States

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Nutritional and Metabolic Diseases

Interventions

sodium phenylbutyrate and taurursodiol

Condition Hierarchy (Ancestors)

Diabetes Mellitus

Study Officials

• Petter M Bjornstad, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Bard, MMS, MS, CCRC

CONTACT

206-685-2069; abard@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Division of Metabolism, Endocrinology, and Nutrition

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NL (1)