New diabetes drug enters early safety testing
NCT ID NCT06945406
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called LY4057996 in 124 healthy volunteers and people with type 1 or type 2 diabetes. The main goal is to see if the drug is safe and what side effects it may cause. Participants receive the drug as a shot under the skin or into a vein, and blood tests measure how the body processes it. The study lasts 4 to 11 weeks, depending on the group.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: Part A for Healthy Participants: * Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment Part A for Type 2 Diabetes (T2DM) Participants: * Are participants with T2DM diagnosed greater than 1 year before enrollment, * On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only) * Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening Part B * Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening * HbA1c 6% to 8.5% inclusive at screening Part C * Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening * HbA1c 6 to 8.5% inclusive at screening All Parts * Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine) * No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants Exclusion Criteria: * Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening * Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening All Parts * Cardiovascular: no significant history of cardiovascular disease (CVD) * Gastrointestinal: have gastroparesis or have undergone gastric surgery * Hepatic: have acute or chronic hepatitis
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes mellitus, type 1 are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Profil Institut für Stoffwechselforschung
RECRUITINGNeuss, 41460, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The effects of external nasal dilator strips on sleep and cardiovascular health
- A pharmacokinetic study of NTI164 in healthy adult volunteers
- Genetic determinants of Exercise-Induced muscle damage (POLYGENDOMUS) / déterminants génétiques des dommages musculaires induits par l'Exercice (POLYGENDOMUS)
- Effectiveness of shared decision Making(SDM)on patients with poor control type 2 diabetes
- A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM)
- Can a simple injection timing reduce bleeding after skin cancer surgery?