HealthyPhase 1NCT05841238
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
A Phase 1 study testing LY3502970 in people with Healthy and Obese, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- LY3502970
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Apr 2023to 13 Nov 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants who are overtly healthy as determined by medical evaluation
- Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
- Participants with a stable body weight, with 5% or less body weight gain or loss
Who cannot join
- Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
- Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
- Have known clinically significant gastric emptying abnormality
- Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
- Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug
- Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Labcorp Clinical Research LP
Dallas, Texas, 75247
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117
LabCorp CRU, Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants
The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
- Being tested
- LY3502970
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3502970Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY3502970 (Periods 1 to 11) | Experimental | Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows:
* Period 1 (Day 1-7): 0.8 milligram (mg) LY3502970 tablet (fasted state)
* Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state)
* Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state)
* Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state)
* Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state)
* Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state)
* Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state)
* Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state)
* Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state)
* Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state)
* Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state) Receives: Drug: LY3502970 |
| Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13) | Experimental | Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows:
* Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state)
* Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state) Receives: Drug: LY3502970 |
| Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13) | Experimental | Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows:
* Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state)
* Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state) Receives: Drug: LY3502970 |
| Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13) | Experimental | Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows:
* Period 12 (Day 78-84): 36 mg LY3502970 dual-fill (DF) capsule (fasted state)
* Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state) Receives: Drug: LY3502970 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: AUC[0-24] of LY3502970 in fasted state
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Cmax of LY3502970 in fasted state
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Tmax of LY3502970 in fasted state
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
Secondary outcomes (3)
PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10
PK: AUC[0-24] of LY3502970 in fed state
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10
PK: Cmax of LY3502970 in fed state
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10
PK: Tmax of LY3502970 in fed state
Measured: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start26 Apr 2023
- Primary completion14 Sep 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT05841238
- Sponsor's protocol ID
- 18527
- Other IDs
- J2A-MC-GZGN
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2023
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants
- ClinicalTrials.gov ID
- NCT05841238
- Acronym / sponsor ID
- 18527
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Posted 10 Jul 2026
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 how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: LY3502970 (Periods 1 to 11) | Experimental | Drug: LY3502970Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows: * Period 1 (Day 1-7): 0.8 milligram (mg) LY3502970 tablet (fasted state) * Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state) * Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state) * Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state) * Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state) * Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state) * Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state) * Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state) * Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state) * Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state) * Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state) |
| Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13) | Experimental | Drug: LY3502970Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state) |
| Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13) | Experimental | Drug: LY3502970Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state) |
| Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13) | Experimental | Drug: LY3502970Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 36 mg LY3502970 dual-fill (DF) capsule (fasted state) * Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants who are overtly healthy as determined by medical evaluation
- Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
- Participants with a stable body weight, with 5% or less body weight gain or loss
Key exclusion criteria (7 listed)
- Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
- Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
- Have known clinically significant gastric emptying abnormality
- Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
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 |
|---|---|---|
| LY3502970Administered orally. | Drug | Part A: LY3502970 (Periods 1 to 11), Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13), Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13), Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: AUC[0-24] of LY3502970 in fasted state
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Cmax of LY3502970 in fasted state
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Tmax of LY3502970 in fasted state
3 secondary outcomes
PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10
Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 LY3502970 in people with Healthy and Obese, 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 3 inclusion and 7 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 10 Jul 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 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. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13 (time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13). The study lists 3 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 10 Jul 2026.