Phase 1 Type 1 Diabetes Trial, Recruiting NCT06945406 Sponsor: Eli Lilly and Company Condition: Type 1 Diabetes
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Phase 1 Type 1 Diabetes Trial, Recruiting

NCT06945406
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Healthy participants (Part A):

  • People who are in good general health, confirmed through a medical check-up including health history, physical examination, blood tests, and a heart screening

People with Type 2 diabetes (Part A):

  • People who were diagnosed with Type 2 diabetes more than 1 year before joining the trial
  • People (in one specific group called Cohort 5) who have been taking a long-acting insulin — such as insulin glargine, insulin detemir, or insulin degludec — at more than 10 units per day for at least 6 months
  • People whose HbA1c (a measure of average blood sugar over several months) is between 6.5% and 9.5% at the initial screening visit

People with Type 1 diabetes (Parts B and C):

  • People who have had Type 1 diabetes for at least 1 year, and whose body produces very little or no insulin of its own (confirmed by a specific blood test called C-peptide)
  • People whose HbA1c is between 6% and 8.5% at the initial screening visit

All participants:

  • People whose blood pressure is below 140/90 mmHg (or below 150/90 mmHg for people with diabetes), and whose resting pulse rate is below 90 beats per minute
  • People with Type 1 or Type 2 diabetes who are aware of when their blood sugar is dropping too low (no history of hypoglycemia unawareness)

Who may not be able to join:

  • People who have visited an emergency room or been hospitalised more than once due to poorly controlled blood sugar (including very high blood sugar or a condition called diabetic ketoacidosis) in the 6 months before screening
  • People who have had a severe low blood sugar episode requiring help from another person, or who have had hypoglycemia unawareness (not feeling the warning signs of low blood sugar), in the 6 months before screening
  • People with a significant history of heart or cardiovascular disease
  • People who have a condition called gastroparesis (where the stomach empties too slowly) or who have had surgery on their stomach
  • People who have active or long-term liver inflammation (hepatitis)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
16 May 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov