ObesityPhase 1NCT06297616
A Study of LY3841136 in Japanese Participants With Obesity or Overweight
A Phase 1 study testing LY3841136 and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in Japan.
Trial summary
The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. 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?
- LY3841136 and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 3 sitesJapan
- Study dates
- 15 Apr 2024to 21 Nov 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 or female participants who agree to contraception requirements
- Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive
- Have had a stable weight for the 3 months
Who cannot join
- Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
- Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- Have a history of chronic medical conditions involving the heart, liver, or kidneys
- Have a history of any malignancy within the past 5 years
- Have a history or presence of a GI disorder
Show all 10Show fewer
- Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity
- Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening
- For participants in Part B, have previously received tirzepatide within 6 months prior to screening
- For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Hakata Clinic
Fukuoka, 812-0025
P-One Clinic
Hachiōji, Tokyo, 192-0071
Sumida Hospital
Sumida-ku, Tokyo, 130-0004
About this study
Official title: A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination With Tirzepatide, in Japanese Participants With Obesity or Overweight
The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.
- Conditions
- Obesity, Overweight
- Being tested
- LY3841136, LY3841136-Placebo, Tirzepatide, Tirzepatide-Placebo
- Keywords
- Obesity Disease, Metabolic Disorders, Body Weight Loss
- Medical subject headings
- Obesity, Overweight, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3841136Drug
Administered SC
LY3841136-PlaceboDrug
Administered SC
TirzepatideDrug
Administered SC
Tirzepatide-PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY3841136 | Experimental | LY3841136 administered subcutaneously (SC) Receives: Drug: LY3841136 |
| Part A: Placebo | Placebo comparator | Placebo administered SC Receives: Drug: LY3841136-Placebo |
| Part B: Tirzepatide + LY3841136-Placebo | Experimental | Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC Receives: Drug: LY3841136-Placebo; Drug: Tirzepatide |
| Part B: LY3841136 + Tirzepatide-Placebo | Experimental | LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC Receives: Drug: LY3841136; Drug: Tirzepatide-Placebo |
| Part B: LY3841136 + Tirzepatide | Experimental | LY3841136 administered SC along with Tirzepatide administered SC Receives: Drug: LY3841136; Drug: Tirzepatide |
| Part B: LY3841136-Placebo + Tirzepatide-Placebo | Placebo comparator | Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC Receives: Drug: LY3841136-Placebo; Drug: Tirzepatide-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Week 22
Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Week 34
Secondary outcomes (6)
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136
PK: AUC of LY3841136 alone
Measured: Predose through Week 22
Part A PK: Maximum Observed Concentration (Cmax) of LY3841136
PK: Cmax of LY3841136 alone
Measured: Predose through Week 22
Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12
PD: Change from baseline in body weight
Measured: Baseline through Week 12
Part B PK: AUC of LY3841136 in Combination with Tirzepatide
PK: AUC of LY3841136 in combination with tirzepatide
Measured: Predose through Week 34
Part B PK: Cmax of LY3841136 in Combination with Tirzepatide
PK: Cmax of LY3841136 in combination with tirzepatide
Measured: Predose through Week 34
Part B PD: Change From Baseline in Body Weight at Week 24
PD: Change from baseline in body weight
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start15 Apr 2024
- Primary completion21 Nov 2025
- Study completion21 Nov 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 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
- NCT06297616
- Sponsor's protocol ID
- 18814
- Other IDs
- J3R-JE-YDAB
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3841136 Monotherapy, and LY3841136 in Combination With Tirzepatide, in Japanese Participants With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT06297616
- Acronym / sponsor ID
- 18814
- Conditions
- Obesity, Overweight
- Keywords
- Obesity Disease, Metabolic Disorders, Body Weight Loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 7 Mar 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 learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: LY3841136 | Experimental | Drug: LY3841136LY3841136 administered subcutaneously (SC) |
| Part A: Placebo | Placebo comparator | Drug: LY3841136-PlaceboPlacebo administered SC |
| Part B: Tirzepatide + LY3841136-Placebo | Experimental | Drug: LY3841136-Placebo, Drug: TirzepatideTirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC |
| Part B: LY3841136 + Tirzepatide-Placebo | Experimental | Drug: LY3841136, Drug: Tirzepatide-PlaceboLY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC |
| Part B: LY3841136 + Tirzepatide | Experimental | Drug: LY3841136, Drug: TirzepatideLY3841136 administered SC along with Tirzepatide administered SC |
| Part B: LY3841136-Placebo + Tirzepatide-Placebo | Placebo comparator | Drug: LY3841136-Placebo, Drug: Tirzepatide-PlaceboVolume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants who agree to contraception requirements
- Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive
- Have had a stable weight for the 3 months
Key exclusion criteria (10 listed)
- Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
- Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
- Have a history of chronic medical conditions involving the heart, liver, or kidneys
- Have a history of any malignancy within the past 5 years
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 |
|---|---|---|
| LY3841136Administered SC | Drug | Part A: LY3841136, Part B: LY3841136 + Tirzepatide, Part B: LY3841136 + Tirzepatide-Placebo |
| LY3841136-PlaceboAdministered SC | Drug | Part A: Placebo, Part B: LY3841136-Placebo + Tirzepatide-Placebo, Part B: Tirzepatide + LY3841136-Placebo |
| TirzepatideAdministered SC | Drug | Part B: LY3841136 + Tirzepatide, Part B: Tirzepatide + LY3841136-Placebo |
| Tirzepatide-PlaceboAdministered SC | Drug | Part B: LY3841136 + Tirzepatide-Placebo, Part B: LY3841136-Placebo + Tirzepatide-Placebo |
Primary outcome
Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22
Time frame: Baseline through Week 22
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34
Time frame: Baseline through Week 34
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
6 secondary outcomes
Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136
Time frame: Predose through Week 22
Part A PK: Maximum Observed Concentration (Cmax) of LY3841136
Time frame: Predose through Week 22
Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12
Time frame: Baseline through Week 12
Part B PK: AUC of LY3841136 in Combination with Tirzepatide
Time frame: Predose through Week 34
Part B PK: Cmax of LY3841136 in Combination with Tirzepatide
Time frame: Predose through Week 34
Part B PD: Change From Baseline in Body Weight at Week 24
Time frame: Baseline through Week 24
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 16 Jan 2026.
- A Study of LY3841136 in Japanese Participants with Obesity or OverweightLink 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 LY3841136 and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in Japan.
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 3 inclusion and 10 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 16 Jan 2026. 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 Japan. 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?
Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22 (time frame: Baseline through Week 22). The study lists 2 primary outcomes in all. 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 16 Jan 2026.