Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of LY3493269 in Participants With Type 2 Diabetes

NCTNCT04515576Other id17530Other idJ1X-MC-GZHC

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 56 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 25 Aug 2020
Primary completion: 9 Mar 2021
Completion: 9 Mar 2021
First posted: 17 Aug 2020
Last update posted: 14 Jan 2025
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 1
A Study of LY3493269 in Participants With Type 2 Diabetes
NCT04515576
25 Aug 2020 to 9 Mar 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.

Interventions

LY3493269Drug
DulaglutideDrug
PlaceboDrug

Arms6

Active comparator
1.5 milligrams (mg) Dulaglutide
Participants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.
Experimental
0.3 mg LY3493269
Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
Experimental
1 mg LY3493269
Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
Experimental
0.75/1.5/3 mg LY3493269
Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
Experimental
1.5/3/4/5 mg LY3493269
Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
Placebo comparator
Placebo
Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame · Baseline through final follow-up at Day 57
Registry description
TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes(3)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Time frame · Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
Registry description
Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Time frame · Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
Registry description
Maximum Observed Drug Concentration (Cmax) of LY3493269
Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose
Time frame · Baseline, Day 29
Registry description
Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline through final follow-up at Day 57

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Group	Value (Participants)
Placebo	0
1.5 mg Dulaglutide	0
0.3 mg LY3493269	0
1 mg LY3493269	0
0.75/1.5/3 mg LY3493269	0
1.5/3/4/5 mg LY3493269	0

Secondary and other outcome results(3)

Secondary outcomeGeometric least squares mean· Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

Group	Value (nanogramhour per milliliter (ngh/mL))	Spread
0.3 mg LY3493269 QW	4220	27
1 mg LY3493269 QW	18500	40
0.75/1.5/3 mg LY3493269 QW	10200	30
1.5/3/4/5 mg LY3493269 QW	22800	25

Secondary outcomeGeometric mean· Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

Group	Value (nanogram per milliliter (ng/mL))	Spread
0.3 mg LY3493269 QW	31.2	31
1 mg LY3493269 QW	153	51
0.75/1.5/3 mg LY3493269 QW	73.6	32
1.5/3/4/5 mg LY3493269 QW	165	34

Secondary outcomeMean· Baseline, Day 29

Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose

Group	Value (millimoles per litre (mmol/L))	Spread
Placebo	-1.07	2.34
1.5 mg Dulaglutide	-4.11	2.82
0.3 mg LY3493269	-2.20	1.47
1 mg LY3493269	-4.83	2.75
0.75/1.5/3 mg LY3493269	-3.61	3.29
1.5/3/4/5 mg LY3493269	-3.98	3.11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.	0 / 7	0 / 7	2 / 7
1.5 mg Dulaglutide QWParticipants received 1.5 mg dulaglutide SC QW for 4 weeks.	0 / 8	0 / 8	5 / 8
0.3 mg LY3493269 QWParticipants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.	0 / 8	0 / 8	5 / 8
1 mg LY3493269 QWParticipants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.	0 / 8	0 / 8	7 / 8
0.75/1.5/3 mg LY3493269 QWParticipants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.	0 / 11	0 / 11	11 / 11
1.5/3/4/5 mg LY3493269 QWParticipants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.	0 / 14	0 / 14	13 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Are male or female not of childbearing potential * Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening * Have had a stable body weight (\<5% body weight change) for the 3 months prior to screening * Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening * Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening * Have an HbA1c of at least 7.0% and no more than 10.5% at screening * Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator Exclusion Criteria: * Have type 1 diabetes mellitus 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 a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment * Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea * Have a history of acute or chronic pancreatitis * Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma * Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening

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