HealthyPhase 1NCT04682106
A Study of LY3493269 in Healthy Participants
A Phase 1 study testing LY3493269 and Salcaprozate Sodium in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3493269 and Salcaprozate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 3 May 2021to 11 Nov 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are male or female not of childbearing potential
- Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
- Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
- Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow blood sampling as per the protocol.
Who cannot join
- Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the IP; or of interfering with the interpretation of data
- Have undergone any form of bariatric surgery
- Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
- Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN)
- Have clinical signs or symptoms of liver disease, acute or chronic hepatitis
Show all 17Show fewer
- Have evidence of significant active neuropsychiatric disease as determined by the investigator
- Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
- Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
- Have participated within the past 30 days of screening in a clinical study involving an investigational product (IP); at least 5 half-lives or 30 days, whichever is longer, should have passed
- Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QTcF greater than (>) 450 milliseconds (msec) for males and > 470 msec for females, short PR interval (< 120 msec), or PR interval > 220 msec, second and third atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome
- Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times (X) ULN or total bilirubin level (TBL) >1.5X ULN
- Show evidence of HIV infection and/or positive human HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen
- Have donated blood of more than 450 mL, or have participated in a clinical study that required similar blood volume drawn within the past 3 calendar months
- Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an LY3493269 Formulation in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening
- Conditions
- Healthy
- Being tested
- LY3493269, Placebo, Salcaprozate Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3493269Drug
Administered orally.
PlaceboDrug
Administered orally.
Salcaprozate SodiumDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo orally once daily (QD) for three consecutive days. Receives: Drug: Placebo |
| 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC) | Experimental | Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. Receives: Drug: LY3493269; Drug: Salcaprozate Sodium |
| 24 mg LY3493269 + 600 mg SNAC | Experimental | Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. Receives: Drug: LY3493269; Drug: Salcaprozate Sodium |
| 12 mg LY3493269 + 300 mg SNAC | Experimental | Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. Receives: Drug: LY3493269; Drug: Salcaprozate Sodium |
| 4 mg LY3493269 + 300 mg SNAC | Experimental | Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. Receives: Drug: LY3493269; Drug: Salcaprozate Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
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.
A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.
Measured: Baseline through Day 44
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269
PK: AUC (0-24) of LY3493269
Measured: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
PK: Maximum Concentration (Cmax) of LY3493269
PK: Cmax of LY3493269
Measured: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start3 May 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682106
- Sponsor's protocol ID
- 17552
- Other IDs
- J1X-MC-GZHF
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2020
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an LY3493269 Formulation in Healthy Participants
- ClinicalTrials.gov ID
- NCT04682106
- Acronym / sponsor ID
- 17552
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo orally once daily (QD) for three consecutive days. |
| 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC) | Experimental | Drug: LY3493269, Drug: Salcaprozate SodiumParticipants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| 24 mg LY3493269 + 600 mg SNAC | Experimental | Drug: LY3493269, Drug: Salcaprozate SodiumParticipants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| 12 mg LY3493269 + 300 mg SNAC | Experimental | Drug: LY3493269, Drug: Salcaprozate SodiumParticipants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
| 4 mg LY3493269 + 300 mg SNAC | Experimental | Drug: LY3493269, Drug: Salcaprozate SodiumParticipants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are male or female not of childbearing potential
- Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
- Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
- Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow blood sampling as per the protocol.
Key exclusion criteria (17 listed)
- Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the IP; or of interfering with the interpretation of data
- Have undergone any form of bariatric surgery
- Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
- Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3493269Administered orally. | Drug | 12 mg LY3493269 + 300 mg SNAC, 24 mg LY3493269 + 600 mg SNAC, 4 mg LY3493269 + 300 mg SNAC, 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC) |
| PlaceboAdministered orally. | Drug | Placebo |
| Salcaprozate SodiumAdministered orally. | Drug | 12 mg LY3493269 + 300 mg SNAC, 24 mg LY3493269 + 600 mg SNAC, 4 mg LY3493269 + 300 mg SNAC, 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC) |
Primary outcome
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
Time frame: Baseline through Day 44
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. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269
Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
PK: Maximum Concentration (Cmax) of LY3493269
Time frame: Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3493269 and Salcaprozate Sodium in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 5 inclusion and 17 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 14 Jan 2025. 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 Singapore. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Treatment-Emergent Adverse Event(s) (TEAEs) (time frame: Baseline through Day 44). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.