A Phase 1 interventional study of LY4057996 SC and LY4057996 IV in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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Among 75 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company — 4 open to participants now, 6 under way, 4 of them phase 3. Diabetes Mellitus, Type 1 · Eli Lilly and Company.
Among the 75 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company, this one is the 25th largest by planned enrollment of the 72 interventional ones that give a count, is one of 3 that started in 2025, is one of 33 in phase 1, and was the 71st registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →4 of the 75 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company are open now, in 12 countries. Recruiting first, the newest first:
Eli Lilly and Company · Sites in United States
Ages 18–70
Eli Lilly and Company · Sites in United States, Australia, Belgium and 17 more countries
Ages 1–35
Eli Lilly and Company · Sites in United States, Australia, Belgium and 16 more countries
Ages 1–35
By country, each count listing its studies:
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 33 · Phase 2 8 · Phase 3 25 · Phase 4 2
First in 2002; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 124 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 62 across the 72 interventional studies, 28 across the 3 observational. Of the 66 that completed or were terminated, 49 (74%) have results posted.
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Eli Lilly and Company is the lead sponsor of 2,108 studies on the registry; 153 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
4 of the studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07803744Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity | 2026-12 |
| NCT06945406Eli Lilly and CompanyA Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes | 2027-03 |
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Among the 75 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part A for Healthy Participants:
Part A for Type 2 Diabetes (T2DM) Participants:
Part B
Part C
All Parts
Exclusion Criteria:
All Parts
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LY4057996 administered subcutaneously (SC) and/or intravenously (IV)
Drug: LY4057996 SC · Drug: LY4057996 IV
Placebo administered SC and/or IV
Drug: Placebo SC · Drug: Placebo IV
LY4057996 administered SC
Drug: LY4057996 SC
LY4057996 and interventions of pre-study basal insulin and Lispro administered SC
Drug: LY4057996 SC · Drug: Lispro SC · Drug: Pre-study basal insulin SC
Degludec administered SC and/or IV
Drug: Degludec SC · Drug: Degludec IV
Degludec administered SC
Drug: Degludec SC
Administered SC
Administered IV
Administered SC
Administered IV
Administered SC
Administered SC
Administered IV
Administered SC
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
A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline to Study Completion (Up to 47 Weeks)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996
PK: AUC of LY4057996
Time frame: Baseline to Study Completion (Up to 47 Weeks)
PK: Maximum Concentration (Cmax) of LY4057996
PK: Cmax of LY4057996
Time frame: Baseline to Study Completion (Up to 47 Weeks)
Pharmacodynamic (PD): Change from Baseline in Fasting Glucose
PD: Change from Baseline in Fasting Glucose
Time frame: Baseline to Study Completion (Up to 47 Weeks)
PD: AUC of Glucose Infusion Rate (GIR)
PD: AUC of GIR
Time frame: Baseline Up to 10 weeks
Plan to share: No
Started May 2025 (actual). Primary completion is estimated for Mar 2027, 22 months after the start.
Of 98 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's planned 22 months is above that.
Counting every sponsor, half of 153 studies reached it within 12 months; a quarter within 5 and three quarters within 32.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Dec 2026 → Mar 2027 and completion Dec 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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