ObesityPhase 1NCT06345066
A Study of LY3841136 in Overweight and Obese Participants
A Phase 1 study testing Tirzepatide and LY3841136 in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Tirzepatide and LY3841136
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Apr 2024to 29 Sep 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants who are overtly healthy as determined by medical evaluation
- Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).
- Have clinical laboratory test results within normal reference range
- Have venous access sufficient to allow for blood sampling
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- Have type 1 or type 2 diabetes mellitus
- Have an abnormal 12-lead electrocardiogram (ECG)
- Have a history or presence of psychiatric disorders
- Have abnormal blood pressure and pulse rate
- Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants
The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.
- Conditions
- Obesity, Overweight
- Being tested
- Tirzepatide, LY3841136, Placebo
- Keywords
- Safety, Tolerability, Body weight
- Medical subject headings
- Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Administered SC.
LY3841136Drug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3841136 + Tirzepatide | Experimental | LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC. Receives: Drug: Tirzepatide; Drug: LY3841136 |
| Placebo + Tirzepatide | Placebo comparator | Placebo administered SC in combination with tirzepatide given SC. Receives: Drug: Tirzepatide; 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 Event(s) (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: Baseline up to 42 weeks
Secondary outcomes (3)
Percent change from baseline in body weight
Measured: Baseline, Week 42
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136
Measured: Predose up to 42 weeks
Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136
Measured: Predose up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start3 Apr 2024
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 96 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
- NCT06345066
- Sponsor's protocol ID
- 18834
- Other IDs
- J3R-MC-YDAC
- Status last verified
- Oct 2025
- First submitted
- 28 Mar 2024
- Last updated
- 15 Oct 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 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Combination Study to Evaluate the Safety and Tolerability of Tirzepatide and LY3841136 in Overweight and Obese Participants
- ClinicalTrials.gov ID
- NCT06345066
- Acronym / sponsor ID
- 18834
- Conditions
- Obesity, Overweight
- Keywords
- Safety, Tolerability, Body weight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 3 Apr 2024 (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 assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3841136 + Tirzepatide | Experimental | Drug: Tirzepatide, Drug: LY3841136LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC. |
| Placebo + Tirzepatide | Placebo comparator | Drug: Tirzepatide, Drug: PlaceboPlacebo administered SC in combination with tirzepatide given SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female participants who are overtly healthy as determined by medical evaluation
- Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).
- Have clinical laboratory test results within normal reference range
- Have venous access sufficient to allow for blood sampling
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Key exclusion criteria (5 listed)
- Have type 1 or type 2 diabetes mellitus
- Have an abnormal 12-lead electrocardiogram (ECG)
- Have a history or presence of psychiatric disorders
- Have abnormal blood pressure and pulse rate
- Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.
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 |
|---|---|---|
| TirzepatideAdministered SC. | Drug | LY3841136 + Tirzepatide, Placebo + Tirzepatide |
| LY3841136Administered SC. | Drug | LY3841136 + Tirzepatide |
| PlaceboAdministered SC. | Drug | Placebo + Tirzepatide |
Primary outcome
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 up to 42 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.
3 secondary outcomes
Percent change from baseline in body weight
Time frame: Baseline, Week 42
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136
Time frame: Predose up to 42 weeks
Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136
Time frame: Predose up to 42 weeks
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 15 Oct 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
3 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 Tirzepatide and LY3841136 in people with Obesity and Overweight, run by Eli Lilly and Company at 3 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 5 inclusion and 5 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 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration (time frame: Baseline up to 42 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 15 Oct 2025.