A Study of LY3041658 in Healthy Participants
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ClinicalTrials.gov Identifier: NCT04653168 |
Recruitment Status :
Recruiting
First Posted : December 4, 2020
Last Update Posted : February 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: LY3041658 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants |
Actual Study Start Date : | December 7, 2020 |
Estimated Primary Completion Date : | May 24, 2021 |
Estimated Study Completion Date : | May 24, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3041658 Low Dose
LY3041658 administered by subcutaneous (SC) injection.
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Drug: LY3041658
Administered SC |
Experimental: LY3041658 High Dose
LY3041658 administered by SC injection.
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Drug: LY3041658
Administered SC |
- Number of Participants With incidence and severity of Injection Site Reaction (ISR) [ Time Frame: Baseline up to Day 15 ]Number of Participants With incidence and severity of ISR
- Visual Analog Scale (VAS) Score for Injection Site Pain [ Time Frame: Baseline up to Day 1 ]VAS Score for Injection Site Pain
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658 [ Time Frame: Predose up to day 85 postdose ]PK: Cmax of LY3041658
- PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658 [ Time Frame: Predose up to day 85 postdose ]PK: AUC(0-inf) of LY3041658

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Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive).
Exclusion Criteria:
- Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data.
- Have self-perceived dullness or loss of sensation on either side of their abdomen.
- Have any condition that could affect pain perception from an injection.
- Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653168
Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@Lilly.com |
Singapore | |
Lilly Centre for Clinical Pharmacology | Recruiting |
Singapore, Singapore, 138623 | |
Contact 64139811 | |
Principal Investigator: Ronan Kelly |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04653168 |
Other Study ID Numbers: |
17745 I7P-MC-DSAE ( Other Identifier: Eli Lilly and Company ) |
First Posted: | December 4, 2020 Key Record Dates |
Last Update Posted: | February 3, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |