Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Two Different Formulations of LY3502970 in Healthy Participants

NCTNCT05341089Other id17785Other idJ2A-MC-GZGH

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 39 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
Singapore
Start: 17 May 2022
Primary completion: 1 Sept 2022
Completion: 1 Sept 2022
First posted: 22 Apr 2022
Last update posted: 27 May 2026
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

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

20222023

Ph 1
A Study of Two Different Formulations of LY3502970 in Healthy Participants
NCT05341089
17 May 2022 to 1 Sept 2022

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 conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.

Interventions

LY3502970Drug

Arms3

Experimental
2 mg/4mg/8mg LY3502970 - Dose Titration Period
Participants received escalating oral doses of LY3502970 according to the following dosing schedule: * Days 1-7: 2 milligrams (mg) once daily (QD) * Days 8-14: 4 mg QD * Days 15-21: 8 mg QD
Experimental
16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period
Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2.
Experimental
16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period
Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2.

Primary outcomes3

Outcomes the sponsor listed as primary.

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2
Time frame · Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
Registry description
PK: Cmax of LY3502970 in Formulation 1 and Formulation 2
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
Time frame · Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
Registry description
PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2
Time frame · Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
Registry description
PK: Tmax of LY3502970 in Formulation 1 and Formulation 2

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 outcomeGeometric mean· Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2

Group	Value (nanogram per milliliter (ng/mL))	Spread
16 mg LY3502970 (Formulation 1)	86.5	40
16 mg LY3502970 (Formulation 2)	86.5	43

Primary outcomeGeometric mean· Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2

Group	Value (Nanogramhour per milliliter (ngh/mL))	Spread
16 mg LY3502970 (Formulation 1)	1260	38
16 mg LY3502970 (Formulation 2)	1240	40

Primary outcomeMedian· Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2

Group	Value (Hours (h))
16 mg LY3502970 (Formulation 1)	6.00
16 mg LY3502970 (Formulation 2)	6.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
2 mg LY3502970 - Dose Titration PeriodParticipants from the dose titration period who received 2 mg LY3502970 were included in this arm.	0 / 38	0 / 38	23 / 38
4 mg LY3502970 - Dose Titration PeriodParticipants from the dose titration period who received 4 mg LY3502970 were included in this arm.	0 / 37	0 / 37	8 / 37
8 mg LY3502970 - Dose Titration PeriodParticipants from the dose titration period who received 8 mg LY3502970 were included in this arm.	0 / 34	0 / 34	17 / 34
16 mg LY3502970 (Formulation 1)Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm.	0 / 33	0 / 33	24 / 33
16 mg LY3502970 (Formulation 2)Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm.	0 / 34	0 / 34	24 / 34

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 21 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation * Participants who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants * Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²) * Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Exclusion Criteria: * Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening * Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening * Participants who have known allergies to LY3502970, related compounds, or any components of the formulation * Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing * Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. A negative test within 6 months of screening would not need to be repeated. * Participants who show evidence of hepatitis C and/or positive hepatitis C antibody, or both. A negative test within 6 months of screening would not need to be repeated. * Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody, or all. A negative test within 6 months of screening would not need to be repeated.

PepBank is a research reference. Talk to a doctor before you use any peptide.