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Diabetes Mellitus, Type 2Phase 1NCT05407961

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

A Phase 1 study testing LY3532226 and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site 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 evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY3532226 and Dulaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteGermany
Study dates
7 Jun 2022to 12 Jan 2024
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
  • Have the following glycosylated hemoglobin (HbA1c) levels at screening:
  • HbA1c >/= 7.0% to </= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and
  • HbA1c >/= 6.0% to </= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor
  • Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
  • Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
  • Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

Who cannot join

  • Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
  • Have a clinically significant abnormality ECG
  • Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome
  • Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or DPP4
  • Have received chronic systemic glucocorticoid therapy (>2 weeks) in the past 6 months
  • Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older)
  • Smoke more than 10 cigarettes, or cigarette equivalent, per day

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für Stoffwechselforschung

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Phase 1b, 2-Part, Investigator- and Participant-Blind, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3532226 in Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.

Being tested
LY3532226, Placebo, Dulaglutide
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.

  • LY3532226Drug

    Administered SC.

  • PlaceboDrug

    Administered SC.

  • DulaglutideDrug

    Also called Trulicity

    Administered SC.

Study groups in NCT05407961
Study groupRoleWhat they receive
LY3532226 + Dulaglutide (Part A)ExperimentalLY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.
Receives: Drug: LY3532226; Drug: Dulaglutide
Placebo + Dulaglutide (Part A)Placebo comparatorPlacebo administered SC followed by dulaglutide administered SC.
Receives: Drug: Placebo; Drug: Dulaglutide
Dulaglutide + Placebo (Part B)Active comparatorDulaglutide administered SC in combination with placebo given SC.
Receives: Drug: Placebo; Drug: Dulaglutide
LY3532226 + Dulaglutide (Part B)ExperimentalLY3532226 administered SC in combination with Dulaglutide given SC.
Receives: Drug: LY3532226; Drug: Dulaglutide
LY3532226 + Placebo (Part B)ExperimentalLY3532226 administered SC in combination with placebo given SC.
Receives: Drug: LY3532226; Drug: Placebo

What is being measured

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

  1. Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

    Measured: Baseline up to Week 16

  2. Part B: Change from Baseline in Total Clamp Disposition Index (cDI)

    Change from Baseline in Total cDI

    Measured: Baseline up to Week 12

Secondary outcomes (8)

  1. Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226

    PK: Cmax of LY3532226

    Measured: Predose on Day 1 through Week 16

  2. Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226

    PK: AUC of LY3532226

    Measured: Predose on Day 1 through Week 16

  3. Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp

    Change from Baseline in ISR from hyperglycaemic clamp

    Measured: Baseline through Week 12

  4. Part B: Change from Baseline in β-cell Glucose Sensitivity (GS) from hyperglycaemic clamp

    Change from Baseline in β-cell GS from hyperglycaemic clamp

    Measured: Baseline through Week 12

  5. Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

    Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

    Measured: Baseline through Week 12

  6. Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT)

    Change from Baseline in Fasting and Post meal Glucose during sMMTT

    Measured: Baseline through Week 16

  7. Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c)

    Change from Baseline in HbA1c

    Measured: Baseline through Week 16

  8. Part A & B: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

    Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT

    Measured: Baseline through Week 16

Timeline

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

  1. First posted7 Jun 2022
  2. Study start7 Jun 2022
  3. Primary completion12 Jan 2024
  4. Study completion12 Jan 2024

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05407961
Sponsor's protocol ID
17835
Other IDs
2021-003257-31, J2V-MC-GZLB
Status last verified
Mar 2024
First submitted
26 May 2022
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3532226 and Dulaglutide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site 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 7 inclusion and 7 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 16). The study lists 2 primary outcomes in all. 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 NCT05407961.

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 29 Mar 2024.

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