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NCT05407961·Phase 1·INTERVENTIONAL

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

DulaglutideOtherCompleted

Status

Completed

Phase

Phase 1

Enrollment

90

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3532226

Administered SC.

DRUG

Placebo

Administered SC.

DRUG

Dulaglutide

Administered SC.

Timeline

From registration to results.

  1. First posted

    Jun 7, 2022

  2. Study start

    Jun 7, 2022

  3. Primary completion

    Jan 12, 2024

  4. Study completion

    Jan 12, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Mar 29, 2024

Outcomes

What the study measures.

Primary outcomes

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

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

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

Time frame · Baseline up to Week 12

Change from Baseline in Total cDI

Secondary outcomes

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

Time frame · Predose on Day 1 through Week 16

PK: Cmax of LY3532226

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

Time frame · Predose on Day 1 through Week 16

PK: AUC of LY3532226

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

Time frame · Baseline through Week 12

Change from Baseline in ISR from hyperglycaemic clamp

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

Time frame · Baseline through Week 12

Change from Baseline in β-cell GS from hyperglycaemic clamp

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

Time frame · Baseline through Week 12

Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value

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

Time frame · Baseline through Week 16

Change from Baseline in Fasting and Post meal Glucose during sMMTT

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

Time frame · Baseline through Week 16

Change from Baseline in HbA1c

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

Time frame · Baseline through Week 16

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening * Have the following glycosylated hemoglobin (HbA1c) levels at screening: 1. HbA1c \>/= 7.0% to \</= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and 2. 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 Exclusion Criteria: * 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

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Profil Institut für Stoffwechselforschung

Neuss, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →