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HealthyPhase 1NCT04641312

A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

A Phase 1 study testing LY3457263 and Dulaglutide in people with Healthy and Type 2 Diabetes, run by Eli Lilly and Company at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 in healthy participants and participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Type 2 Diabetes
What is being tested?
LY3457263 and Dulaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
2 sitesGermany
Study dates
25 Nov 2020to 21 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males that agree to use an effective method of contraception or agree to remain abstinent
  • Females that are not of childbearing potential due to postmenopausal status or due to surgical sterility
  • Part A only:
  • Are overtly healthy
  • Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²)
  • Part B only:
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  • Have been diagnosed with Type 2 Diabetes (T2D) for at least 6 months prior to screening
  • Be treated for T2D with stable dose of metformin, a stable dose of a dipeptidyl peptidase-4 (DPP-4) inhibitor with or without metformin, or a stable dose of a glucagon-like peptide-1 (GLP-1) receptor agonist with or without metformin for at least 3 months prior to screening
  • BMI of 27 to 40 kg/m²

Who cannot join

  • Have undergone any form of bariatric surgery
  • Have used or intend to use medications that promote weight loss within 3 months prior to screening, for the duration of the study
  • Part A only:
  • Have fasting plasma glucose (PG) levels ≥7 millimoles per liter (mmol/L) (≥126 milligrams per deciliter (mg/dL)) at screening
  • Have Hemoglobin A1c (HbA1c) level ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening
  • Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >20% and 10%, above the upper limit of normal (ULN), respectively. Elevation of total bilirubin level is considered acceptable in case of Gilbert's disease (with a normal direct bilirubin)
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  • Part B only:
  • Have Type 1 Diabetes or latent autoimmune diabetes in adults
  • Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
  • Have known proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy
  • Present comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) unless they are well-controlled with stable medication
  • Have had an episode of severe hypoglycaemia within 6 months prior to screening, or have a history of hypoglycaemia unawareness or poor recognition of hypoglycaemia
  • Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase >2 × ULN at screening
  • Have a resting heart rate of <50 or >100 beats per minute
  • Have an estimated glomerular filtration rate (<60 milliliter/minute (mL/min)/1.73 m2, or a level of estimated glomerular filtration rate that would contraindicate the use of metformin per the label in the respective country
  • Have a screening calcitonin ≥20.0 picograms per milliliter (pg/mL)
  • Fasting serum triglyceride level of >500 mg/dL at screening
  • Have serum AST or ALT >3 × ULN or TBL >1.5 × ULN (except for participants diagnosed with Gilbert's syndrome)
  • Have taken any prescription medication that are specifically indicated for lowering serum triglycerides within the last 3 months
  • Have taken within the last 3 months any medications that interfere with absorption of dietary cholesterol or fats
  • Use of medications known to prolong the QT/QTc interval
  • Treated only with diet and exercise at study entry

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Profil Mainz

    Mainz, 55116

  • Profil Institut für Stoffwechselforschung

    Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 in Healthy Participants and in Patients With Type 2 Diabetes

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 in healthy participants and participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study has two parts (part A and B). Each part will last up to 10 weeks and may include up to either 13 (part A) or 19 (part B) visits.

Being tested
LY3457263, Dulaglutide, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3457263Drug

    Administered SC

  • DulaglutideDrug

    Also called LY2189265

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT04641312
Study groupRoleWhat they receive
LY3457263 - Part AExperimentalEscalating single doses of LY3457263 administered subcutaneously (SC) to healthy participants
Receives: Drug: LY3457263
Placebo - Part APlacebo comparatorPlacebo administered SC to healthy participants
Receives: Drug: Placebo
LY3457263 - Part BExperimentalEscalating single doses of LY3457263 administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes
Receives: Drug: LY3457263; Drug: Dulaglutide
Placebo - Part BPlacebo comparatorPlacebo administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes
Receives: Drug: Dulaglutide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Measured: Baseline through Day 42

Secondary outcomes (1)

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3457263

    PK: AUC[0-inf] of LY3457263

    Measured: Day 1 through Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start25 Nov 2020
  3. Primary completion21 Dec 2021
  4. Study completion21 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04641312
Sponsor's protocol ID
17261
Other IDs
2020-001828-34, J1R-MC-GZFA
Status last verified
1 Jan 2022
First submitted
20 Nov 2020
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Briere DA, Leohr JK, Linnebjerg H, Muppidi A, Antonellis M, Antonellis P, Suter TM, Smith LaBell E, Lopes D, Dogra M, Coskun T, Alsina-Fernandez J, Mather KJ. Nisotirostide (LY3457263), a novel NPY2 receptor agonist for type 2 diabetes and obesity: From discovery to clinical proof of concept. Mol Metab. 2026 Oct 3:102452. doi: 10.1016/j.molmet.2026.102452. Online ahead of print.

    PubMed 42829171

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3457263 and Dulaglutide in people with Healthy and Type 2 Diabetes, run by Eli Lilly and Company at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04641312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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