Rheumatoid Arthritis (RA)Phase 1NCT07258849
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
A Phase 1 study testing LY4213663 in people with Rheumatoid Arthritis (RA), run by Eli Lilly and Company at 10 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- LY4213663
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 2 Dec 2025to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m²), inclusive
- Part C and D Only:
- Have a body weight at least 50 kilograms and BMI within the range 18.0 to 40.0 kg/m² (inclusive) at screening
- Have a diagnosis of adult-onset RA for at least 3 months prior to screening
Who cannot join
- Healthy Participants for SAD Part A and MAD Part B Only:
- Have a history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Participants with RA for Parts C and D Only:
- Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria
- Have a 12-lead electrocardiogram (ECG) abnormality at screening
- Have a current or recent acute active infection
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
10 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
256-236-0055, ext 101
Vishala Chindalore
- Recruiting
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
727-466-0078
Robert Levin
- Recruiting
GNP Research at Mark Jaffe, MD
Cooper City, Florida, 33024
754-248-3589
Mark Jaffe
- Recruiting
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
866-429-3700
Sharrell Cooper
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012
704-526-6864
WILSON CUEVA
- Recruiting
Oasis Clinical Research
Las Vegas, Nevada, 89121
702-832-1369
Stephen Tam
- Recruiting
Advanced Pharma CR, LLC
Miami, Florida, 33417
305-220-2727, Ext 802
Simon Abelson
- Recruiting
Floridian Clinical Research
Miami Lakes, Florida, 33016
305-330-9977
Christopher Mesa
- Recruiting
Arizona Research Center
Phoenix, Arizona, 85053
602-773-3020
Louise Taber
Germany1 site, 1 recruiting
- Not yet recruiting
Universitätsklinikum Charité
Berlin, 10117
+49 30 450 539 200
Stanislav Ignatenko
About this study
Official title: A Phase 1, Multicenter, Randomized, Placebo-Controlled, Investigator- and Participant-Blinded, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4213663 in Healthy Participants, and Two Open-Label, Multiple-Dose Evaluations of LY4213663 in Patients With Rheumatoid Arthritis.
The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- LY4213663, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4213663Drug
Administered SC
LY4213663Drug
Administered IV
PlaceboDrug
Administered SC
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4213663 (Part A) | Experimental | Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants Receives: Drug: LY4213663 |
| Placebo (Part A) | Placebo comparator | SAD placebo administered SC and IV Receives: Drug: Placebo |
| LY4213663 (Part B) | Experimental | Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants Receives: Drug: LY4213663 |
| Placebo (Part B) | Placebo comparator | MAD placebo administered SC and IV Receives: Drug: Placebo |
| LY4213663 (Parts C and D) | Experimental | Multiple doses of LY4213663 administered SC and IV in participants with RA Receives: Drug: LY4213663 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to Week 33
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663
PK: Cmax of LY4213663
Measured: Baseline up to Week 33
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663
PK: AUC of LY4213663
Measured: Baseline up to Week 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start2 Dec 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- None (open label)
- Enrolment
- 141 participants (estimated)
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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258849
- Sponsor's protocol ID
- 27749
- Other IDs
- 2025-523980-39-00, J6T-MC-KYAA, 2025
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2025
- Last updated
- 23 Jun 2026
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Randomized, Placebo-Controlled, Investigator- and Participant-Blinded, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4213663 in Healthy Participants, and Two Open-Label, Multiple-Dose Evaluations of LY4213663 in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07258849
- Acronym / sponsor ID
- 27749
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 2 Dec 2025 (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 purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LY4213663 (Part A) | Experimental | Drug: LY4213663Single-ascending dose (SAD) of LY4213663 administered subcutaneously (SC) and intravenously (IV) in healthy participants |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboSAD placebo administered SC and IV |
| LY4213663 (Part B) | Experimental | Drug: LY4213663Multiple-ascending doses (MAD) of LY4213663 administered SC and IV in healthy participants |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboMAD placebo administered SC and IV |
| LY4213663 (Parts C and D) | Experimental | Drug: LY4213663Multiple doses of LY4213663 administered SC and IV in participants with RA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m²), inclusive
- Have a body weight at least 50 kilograms and BMI within the range 18.0 to 40.0 kg/m² (inclusive) at screening
- Have a diagnosis of adult-onset RA for at least 3 months prior to screening
Key exclusion criteria (6 listed)
- Have a history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria
- Have a 12-lead electrocardiogram (ECG) abnormality at screening
- Have a current or recent acute active infection
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 |
|---|---|---|
| LY4213663Administered SC | Drug | LY4213663 (Part A), LY4213663 (Part B), LY4213663 (Parts C and D) |
| LY4213663Administered IV | Drug | LY4213663 (Part A), LY4213663 (Part B), LY4213663 (Parts C and D) |
| PlaceboAdministered SC | Drug | Placebo (Part A), Placebo (Part B) |
| PlaceboAdministered IV | Drug | Placebo (Part A), Placebo (Part B) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Week 33
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4213663
Time frame: Baseline up to Week 33
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4213663
Time frame: Baseline up to Week 33
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid ArthritisLink 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4213663 in people with Rheumatoid Arthritis (RA), run by Eli Lilly and Company at 10 sites in 2 countries.
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 6 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 33). 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 23 Jun 2026.