HealthyPhase 1NCT06692348
A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants
A Phase 1 study testing Orforglipron in people with Healthy, run by Eli Lilly and Company at 3 sites in Japan.
Trial summary
The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 3 sitesJapan
- Study dates
- 13 Dec 2024to 9 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m²), inclusive
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- 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 a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%
- Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m²)
- Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the 2 years prior to screening
- Actively suicidal and therefore deemed to be at significant risk for suicide
- Have a known clinically significant gastric emptying abnormality
- Have history or presence of acute or chronic pancreatitis or an elevation in serum lipase or amylase levels greater than 3 times the upper limit of normal (ULN)
- Have an abnormal blood pressure (BP), pulse rate, or both
- Have difficulty swallowing capsules
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Hakata Clinic
Fukuoka, 812-0025
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
Sumida Hospital
Sumida-ku, Tokyo, 130-0004
About this study
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants
The main purpose of this study is to assess and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.
- Conditions
- Healthy
- Being tested
- Orforglipron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Orforglipron | Experimental | Participants will receive different sequences of Orforglipron doses administered as either single capsule or multiple capsules at different dose levels under either fasted or fed condition. Receives: Drug: Orforglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)
PK: Steady-state AUC of Orforglipron (Fasted State)
Measured: Week 3 Through Week 16
PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)
PK: Steady-state Cmax of Orforglipron (Fasted State)
Measured: Week 3 Through Week 16
PK: Steady-state AUC of Orforglipron (Fed State)
PK: Steady-state AUC of Orforglipron (Fed State)
Measured: Week 3 Through Week 16
PK: Steady-state Cmax of Orforglipron (Fed State)
PK: Steady-state Cmax of Orforglipron (Fed State)
Measured: Week 3 Through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start13 Dec 2024
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 86 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
- NCT06692348
- Sponsor's protocol ID
- 27228
- Other IDs
- J2A-JE-GZPM
- Status last verified
- Jun 2025
- First submitted
- 14 Nov 2024
- Last updated
- 24 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple-Dose Study to Investigate the Comparability of the Pharmacokinetics of Orforglipron (LY3502970) Single Capsule and Multiple Capsules in Healthy Participants
- ClinicalTrials.gov ID
- NCT06692348
- Acronym / sponsor ID
- 27228
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 18 Nov 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 and compare a single capsule and multiple capsules of Orforglipron based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants under fasted and fed conditions. How the body handles and eliminates the study drug after meals and on an empty stomach will be measured. Information about any adverse effects experienced will be collected and the safety and tolerability of Orforglipron will also be evaluated. The study will last approximately 21 weeks, including a screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orforglipron | Experimental | Drug: OrforglipronParticipants will receive different sequences of Orforglipron doses administered as either single capsule or multiple capsules at different dose levels under either fasted or fed condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a stable body weight, that is, less than a 5% body weight change, for 1 month prior to randomization and body mass index (BMI) within the range 23.0 to 35.0 kilogram per square meter (kg/m²), inclusive
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- 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 (8 listed)
- Have a hemoglobin A1c (HbA1c) test level greater than or equal to 6.5%
- Have an estimated glomerular filtration rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73m²)
- Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder, for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder within the 2 years prior to screening
- Actively suicidal and therefore deemed to be at significant risk for suicide
- Have a known clinically significant gastric emptying abnormality
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 |
|---|---|---|
| OrforglipronAlso: LY3502970Administered orally | Drug | Orforglipron |
Primary outcome
Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State)
Time frame: Week 3 Through Week 16
PK: Steady-state AUC of Orforglipron (Fasted State)
PK: Steady-state Maximum Concentration (Cmax) of Orforglipron (Fasted State)
Time frame: Week 3 Through Week 16
PK: Steady-state Cmax of Orforglipron (Fasted State)
PK: Steady-state AUC of Orforglipron (Fed State)
Time frame: Week 3 Through Week 16
PK: Steady-state AUC of Orforglipron (Fed State)
PK: Steady-state Cmax of Orforglipron (Fed State)
Time frame: Week 3 Through Week 16
PK: Steady-state Cmax of Orforglipron (Fed State)
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 24 Jun 2025.
- 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 Orforglipron in people with Healthy, 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 4 inclusion and 8 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 24 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 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. 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?
Pharmacokinetics (PK): Steady-state Area Under the Concentration Versus Time Curve (AUC) of Orforglipron (Fasted State) (time frame: Week 3 Through Week 16). The study lists 4 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 24 Jun 2025.