Could a metabolic modulator help people with type 1 diabetes use insulin better?
NCT ID NCT07699380
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This study tests whether a drug called AMX0035 can improve how the body responds to insulin in adults with type 1 diabetes. Participants take either AMX0035 or a placebo daily for 24 weeks. Researchers measure insulin sensitivity using a glucose clamp test and track blood sugar control with continuous monitors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AMX0035 (sodium phenylbutyrate + taurursodiol)
- What this could lead to
- If it works, this could point toward a new way to improve insulin sensitivity and metabolic control in people with type 1 diabetes, potentially reducing insulin needs.
- What could go wrong
- This is a mid-stage trial with only 60 participants, so results may not apply broadly. The drug may not improve insulin sensitivity or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 all study procedures Exclusion Criteria: 1. History of pancreatic disease (including pancreatitis) or pancreatic surgery 2. History of cardiovascular disease or stroke within the past 6 months 3. History of heart failure per New York Heart Association criteria 4. History of severe edema or salt restriction requirement 5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids 6. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m² 7. Liver disease (ALT/AST \>3x upper limit of normal \[ULN\]) 8. Pregnancy, breastfeeding, or planning pregnancy during the study period 9. Known hypersensitivity to study drug components 10. Abnormal baseline ECG 11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone) 12. Chronic use of anticoagulants 13. 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 14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein 15. History of severe hypoglycemia requiring assistance within the past 3 months 16. History of diabetic ketoacidosis (DKA) within the past 3 months 17. Personal or family history of breast cancer or ovarian cancer 18. Current participation in another clinical trial 19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC
NOT_YET_RECRUITINGAmsterdam, Netherlands
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University of Washington Medicine Diabetes Institute (UWMDI)
RECRUITINGSeattle, Washington, 98109, United States
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