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Type 1 Diabetes (T1D)Phase 2MetMod-T1DNCT07699380

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

A Phase 2 study testing AMX0035 in people with Type 1 Diabetes (T1D) and Metabolic Diseases, run by University of Washington at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 69 years
What is being tested?
AMX0035
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesin 2 countries
Study dates
Sep 2026to Dec 2029
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • Liver disease (ALT/AST >3x upper limit of normal [ULN]) or severe hepatic impairment (defined as Child-Pugh Class C)
  • 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 CYP2C9, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein
  • History of severe hypoglycemia requiring assistance within the past 3 months
  • History of diabetic ketoacidosis (DKA) within the past 3 months
  • Personal or family history of breast cancer or ovarian cancer
  • Current participation in another clinical trial
  • Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Amanda Bard, MMS, MS, CCRC contact

206-685-2069

abard@uw.edu

2 sites in 2 countries

United States1 site, 1 recruiting

  • University of Washington Medicine Diabetes Institute (UWMDI)

    Seattle, Washington, 98109

    Amanda Bard, MMS, MS, CCRC, 206-685-2069, abard@uw.edu

    Petter Bjornstad, MD

    Recruiting

Other trials in United States

Netherlands1 site, 1 recruiting

  • Amsterdam UMC

    Amsterdam

    Hayo Osmani, 316 50 01 86 08, h.o.osmani@amsterdamumc.nl

    Daniël van Raalte, MD, PhD

    Not yet recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

This is a randomized, double-blind, parallel-group clinical trial to evaluate 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). Following screening and baseline assessments, eligible participants will be randomized 1:1 to receive either AMX0035 or placebo, with stratification by sex and body mass index (≥30 vs. <30 kg/m2). Participants will undergo comprehensive metabolic phenotyping at baseline and 24 weeks, including hyperinsulinemic-euglycemic clamp studies, body composition imaging, continuous glucose monitoring, and tissue biopsies (skeletal muscle and adipose) for assessment of mitochondrial function and biological markers. Participants, clinicians administering the intervention, and laboratory personnel analyzing the samples will remain blinded to treatment assignments throughout the study.

Being tested
AMX0035, Placebo
Medical subject headings
Diabetes Mellitus, Type 1, Metabolic Diseases, Glucose Metabolism Disorders, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases, Nutritional and Metabolic Diseases

What participants receive

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

  • AMX0035Drug

    AMX0035 sachets

  • PlaceboDrug

    Placebo sachets

Study groups in NCT07699380
Study groupRoleWhat they receive
AMX0035ExperimentalParticipants 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.
Receives: Drug: AMX0035
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: Baseline, 24 weeks

Secondary outcomes (5)

  1. Changes in glycemic control

    Glycemic control will be evaluated via continuous glucose monitoring (CGM) and HbA1c.

    Measured: Baseline, 24 weeks

  2. Changes in body composition

    Body composition, including total, regional, visceral, and hepatic fat, will be quantified using DXA and multiparametric MRI.

    Measured: Baseline, 24 weeks

  3. Changes in immune and metabolic biomarkers

    • Circulating and peripheral blood mononuclear cell (PBMC)-based biomarkers of inflammation and oxidative stress will be measured.
    • Associations between these biological markers and insulin sensitivity or glycemic metrics will be examined using multivariable models.

    Measured: Baseline, 24 weeks

  4. Changes in mitochondrial function

    Skeletal muscle and adipose tissue biopsies will be analyzed for ER stress, inflammation, and insulin signaling. Skeletal muscle tissue will also undergo assessment of mitochondrial function by ex vivo respiration.

    Measured: Baseline, 24 weeks

  5. Establish the safety and tolerability of AMX0035 in adults with T1D

    • Adverse events including hypoglycemia, DKA, and changes in hepatic and renal function will be closely monitored throughout the study.
    • Tolerability will be assessed through participant-reported symptoms, including gastrointestinal side effects and study discontinuations.
    • An independent Data Safety Monitoring Board (DSMB) will periodically review unblinded safety data and provide guidance.

    Measured: Duration of study

Timeline

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

  1. First posted13 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699380
Sponsor's protocol ID
MetMod-T1D-AMX0035
Acronym
MetMod-T1D
Status last verified
Sep 2026
First submitted
23 Jun 2026
Last updated
15 Sep 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 AMX0035 in people with Type 1 Diabetes (T1D) and Metabolic Diseases, run by University of Washington at 2 sites in 2 countries.

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 19 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Netherlands. 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?

Contact Amanda Bard, MMS, MS, CCRC (206-685-2069, abard@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp (time frame: Baseline, 24 weeks). 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 NCT07699380.

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 15 Sep 2026.

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