AMX0035 for Type 1 Diabetes
METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)
Recruiting
Phase 2
Interventional Study
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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 69
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- University of Washington · Other
Who this trial is looking for
This trial is looking for adults with Type 1 Diabetes who are currently using insulin. Participants will take either the study drug AMX0035 or a placebo for 24 weeks to see how it affects their condition.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 70 years old.
- I have been diagnosed with Type 1 Diabetes for at least one year.
- I currently use insulin for my diabetes.
- My HbA1c level is less than 9.5%.
- My BMI is between 18.5 and 40.
- I am on a stable dose of RASB or statin, if required.
- I am willing and able to follow all study procedures.
You may not be able to join if
- I have a history of pancreatic disease or surgery.
- I have had a heart attack or stroke in the last 6 months.
- I have been diagnosed with heart failure.
- I have a history of severe swelling or need to restrict salt intake.
- I have liver disease.
- I am pregnant, breastfeeding, or planning to become pregnant.
- I have had severe low blood sugar that required assistance in the last 3 months.
- I am currently in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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About This Trial
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 recr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults ≥18 years to \<70 years of age with established T1D (duration ≥1 year)
2. Currently on insulin therapy (multiple daily injections or insulin pump)
3. HbA1c \<9.5%
4. BMI 18.5-40 kg/m2
5. On stable dose of RASB or statin, if indicated
6. Willing and able to comply with …
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