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Diabetes Mellitus, Type 2Phase 1NCT05327595

A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM)

A Phase 1 study testing LY3549492, Atorvastatin and Midazolam 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 LY3549492 in participants with T2DM. Blood tests will be done to check how much LY3549492 gets into the bloodstream and how the body handles LY3549492. This study has two parts. Each participant will enroll in only one part. 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?
LY3549492, Atorvastatin and Midazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteGermany
Study dates
9 May 2022to 22 Apr 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 T2DM for at least 6 months, as defined by the American Diabetes Association or the World Health Organization,
  • treated with diet and exercise and stable dose(s) of metformin, with or without 1 other oral antidiabetic medication (OAM) at stable dose, 3 months prior to study entry
  • If taking statins, must be on stable statin treatment without a history of statin myopathy for at least 3 months
  • with a glycated hemoglobin (HbA1c) value of
  • greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.5% at screening on metformin only and
  • ≥6.5% and ≤9.5% on metformin in combination with OAMs other than metformin.
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  • Body weight ≥45.0 kilograms (kg) and body mass index within the range of 18.5 to 45.0 kilogram per square meter (kg/m²) (inclusive).
  • Stable body weight for the 3 months prior to screening
  • Women must not be of childbearing potential.

Who cannot join

  • Women of childbearing potential.
  • Have type 1 diabetes mellitus, known latent autoimmune diabetes in adults, or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in 6 months prior to screening.
  • Have active proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment
  • Present with uncontrolled comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia) or have had changes to medication for those conditions within 1 month prior to screening.
  • Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to screening visit, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Any participant that the investigator feels will not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded.
  • Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, gastric banding ), and/or device-based therapy for obesity, or have had device removal within the past 6 months.
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  • Have active or symptomatic gastric ulceration or chronic gastritis.
  • Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation or an abnormal thyroid stimulating hormone (for those with current or previous thyroid history) that, in the opinion of the investigator, would pose a risk to participant safety.
  • Have known definitive diagnosis of autonomic neuropathy as evidenced by neuropathic urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea.
  • Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome.
  • A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of long QT syndrome, use of concomitant medications that prolong the QT/QTc interval).
  • Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
  • Have a significant history (within the past 6 months) of or current comorbidities capable of altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data. These include cardiovascular, respiratory diseases, renal diseases, gastrointestinal (GI) diseases, hematological diseases, neurological diseases, dermatological diseases
  • Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase levels (>2.5 fold the upper limit of normal [ULN]).
  • Have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
  • Have a serum calcitonin level of
  • ≥20.0 picograms per milliliter (pg/mL) at screening, if estimated glomerular filtration rate is ≥60 milliliters per minute per 1.73 m² (mL/min/1.73 m²)
  • ≥35.0 pg/mL at screening, if estimated glomerular filtration rate is <60 mL/min/1.73 m²
  • Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine transaminase [ALT] and aspartate aminotransferase [AST]) greater than 2 × ULN.
  • Have total bilirubin level (TBL) >1.5 × ULN (except for participants diagnosed with Gilbert's syndrome).

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 Randomized, Double-Blind, Multiple-Ascending Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Patients With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in participants with T2DM. Blood tests will be done to check how much LY3549492 gets into the bloodstream and how the body handles LY3549492. This study has two parts. Each participant will enroll in only one part. The study will last either 12 or 13 weeks, depending on part.

Being tested
LY3549492, Placebo, Atorvastatin, Midazolam
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.

  • LY3549492Drug

    Administered orally.

  • PlaceboDrug

    Administered orally.

  • AtorvastatinDrug

    Administered orally.

  • MidazolamDrug

    Administered orally.

Study groups in NCT05327595
Study groupRoleWhat they receive
LY3549492 (Part A)ExperimentalLY3549492 administered orally as multiple ascending doses.
Receives: Drug: LY3549492
Placebo (Part A)Placebo comparatorPlacebo administered orally.
Receives: Drug: Placebo
LY3549492 + Midazolam + Atorvastatin (Part B)ExperimentalLY3549492 coadministered orally with midazolam and atorvastatin.
Receives: Drug: LY3549492; Drug: Atorvastatin; Drug: Midazolam
Placebo + Midazolam + Atorvastatin (Part B)Placebo comparatorPlacebo coadministered orally with midazolam and atorvastatin.
Receives: Drug: Placebo; Drug: Atorvastatin; Drug: Midazolam

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 final follow-up at approximately Day 49

Secondary outcomes (4)

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492

    PK: AUC of LY3549492

    Measured: Day 1 predose up to Day 35

  2. PK: Maximum Concentration (Cmax) of LY3549492

    PK: Cmax of LY3549492

    Measured: Day 1 predose up to Day 35

  3. Pharmacodynamics (PD): Change from Baseline to Day 28 in Fasting Glucose

    PD: Change from Baseline to Day 28 in Fasting Glucose

    Measured: Baseline, Day 28

  4. PD: Change from Baseline to Day 28 in Oral Glucose Tolerance (OGTT) 2 Hour Glucose

    PD: Change from Baseline to Day 28 in OGTT 2 Hour Glucose

    Measured: Baseline, Day 28

Timeline

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

  1. First posted14 Apr 2022
  2. Study start9 May 2022
  3. Primary completion22 Apr 2024
  4. Study completion22 Apr 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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327595
Sponsor's protocol ID
18188
Other IDs
J3H-MC-GZNB, 2021-002220-20
Status last verified
May 2024
First submitted
8 Apr 2022
Last updated
30 May 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 LY3549492, Atorvastatin and Midazolam 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 9 inclusion and 20 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 30 May 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?

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 final follow-up at approximately Day 49). 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 NCT05327595.

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 30 May 2024.

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