OverweightPhase 1NCT05380323
A Study of LY3541105 in Healthy and Overweight Participants
A Phase 1 study testing LY3541105 in people with Overweight and Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy
- What is being tested?
- LY3541105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2022to 27 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants who are overtly healthy as determined by medical evaluation
- Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
- Have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.5 to less than (<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of >/=27 to <40 kg/m², both inclusive (in Part B and C)
- Have had a stable weight for the last 3 months
Who cannot join
- Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
- Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
- Have history or current evidence of a clinically significant cardiovascular condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PRA International
Lenexa, Kansas, 66219
ICON Early Phase Services
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.
- Conditions
- Overweight, Healthy
- Being tested
- LY3541105, Placebo
- Keywords
- Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3541105Drug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3541105 (Part A) | Experimental | Single ascending doses of LY3541105 administered subcutaneously (SC). Receives: Drug: LY3541105 |
| LY3541105 (Part B) | Experimental | Multiple ascending doses of LY3541105 administered SC. Receives: Drug: LY3541105 |
| LY3541105 (Part C) | Experimental | Escalating doses of LY3541105 administered SC. Receives: Drug: LY3541105 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| Placebo (Part B) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
| Placebo (Part C) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
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 Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Predose up to 26 weeks
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
PK: AUC of LY3541105
Measured: Predose through day 43 (Part A) & day 78 (Part B)
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
PK: Tmax of LY3541105
Measured: Predose through day 43 (Part A) & day 78 (Part B)
PK: Maximum Observed Concentration (Cmax) of LY3541105
PK: Cmax of LY3541105
Measured: Predose through day 43 (Part A) & day 78 (Part B)
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight
PD: Absolute and Percentage Change from Baseline in Body Weight
Measured: Predose through week 26 (Part B Only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start10 May 2022
- Primary completion27 Aug 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 206 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
- NCT05380323
- Sponsor's protocol ID
- 18350
- Other IDs
- J3S-MC-YEAA
- Status last verified
- Jun 2025
- First submitted
- 1 May 2022
- Last updated
- 27 Jun 2025
- Results posted
- No
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants
- ClinicalTrials.gov ID
- NCT05380323
- Acronym / sponsor ID
- 18350
- Conditions
- Overweight, Healthy
- Keywords
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
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 LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3541105 (Part A) | Experimental | Drug: LY3541105Single ascending doses of LY3541105 administered subcutaneously (SC). |
| LY3541105 (Part B) | Experimental | Drug: LY3541105Multiple ascending doses of LY3541105 administered SC. |
| LY3541105 (Part C) | Experimental | Drug: LY3541105Escalating doses of LY3541105 administered SC. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
| Placebo (Part C) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are overtly healthy as determined by medical evaluation
- Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
- Have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.5 to less than (<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of >/=27 to <40 kg/m², both inclusive (in Part B and C)
- Have had a stable weight for the last 3 months
Key exclusion criteria (3 listed)
- Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
- Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
- Have history or current evidence of a clinically significant cardiovascular condition
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 |
|---|---|---|
| LY3541105Administered SC. | Drug | LY3541105 (Part A), LY3541105 (Part B), LY3541105 (Part C) |
| PlaceboAdministered SC. | Drug | Placebo (Part A), Placebo (Part B), Placebo (Part C) |
Primary outcome
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: Predose up to 26 weeks
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3541105
Time frame: Predose through day 43 (Part A) & day 78 (Part B)
PK: Time of Maximum observed Concentration (Tmax) of LY3541105
Time frame: Predose through day 43 (Part A) & day 78 (Part B)
PK: Maximum Observed Concentration (Cmax) of LY3541105
Time frame: Predose through day 43 (Part A) & day 78 (Part B)
Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight
Time frame: Predose through week 26 (Part B Only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3541105 in people with Overweight and Healthy, run by Eli Lilly and Company at 2 sites in United States.
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 4 inclusion and 3 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 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Predose up to 26 weeks). 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 27 Jun 2025.