HealthyPhase 1NCT06440980
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
A Phase 1 study testing Orforglipron in people with Healthy and Obese, run by Eli Lilly and Company at 7 sites in United States.
Trial summary
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obese, Overweight
- 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
- 533 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Jun 2024to 2 Jun 2025
- Phase
- Phase 1
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
- Participants who are overtly healthy as determined by medical history and physical examination.
- Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²).
- Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Have venous access sufficient to allow for blood sampling.
Who cannot join
- Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
- Have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions.
- Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years.
- 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)
Show all 11Show fewer
- Have a 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 an abnormal 12-lead electrocardiogram (ECG) at screening.
- Have history of pancreatitis.
- Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
- Have difficulty swallowing capsules or tablets.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
Altasciences Company Inc.
Overland Park, Kansas, 66212
QPS
Springfield, Missouri, 65802
About this study
Official title: A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated.
The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.
- Conditions
- Healthy, Obese, Overweight, Obesity
- Being tested
- Orforglipron
- Keywords
- Pharmacokinetics
- Medical subject headings
- Obesity, Overweight
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 |
|---|---|---|
| Part A: LY3502970 QD Oral Administration (Cohort 1A, Sequence 1) | Experimental | Participants received LY3502970 orally once daily (QD) across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule)
* Period 2: Dose Level 2 (Tablet)
* Period 3: Dose Level 1 (Tablet)
* Period 4: Dose Level 3 (Tablet)
* Period 5: 3 mg (Capsule)
* Period 6: Dose Level 5 (Tablet)
* Period 7: Dose Level 4 (Tablet)
* Period 8: Dose Level 6 (Tablet)
* Period 9: 6 mg (Capsule)
* Period 10: Dose Level 8 (Tablet)
* Period 11: Dose Level 7 (Tablet)
* Period 12: Dose Level 9 (Tablet) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 2) | Experimental | Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 2 (Tablet)
* Period 2: 1 mg (Capsule)
* Period 3: Dose Level 3 (Tablet)
* Period 4: Dose Level 1 (Tablet)
* Period 5: Dose Level 5 (Tablet)
* Period 6: 3 mg (Capsule)
* Period 7: Dose Level 6 (Tablet)
* Period 8: Dose Level 4 (Tablet)
* Period 9: Dose Level 8 (Tablet)
* Period 10: 6 mg (Capsule)
* Period 11: Dose Level 9 (Tablet)
* Period 12: Dose Level 7 (Tablet) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 3) | Experimental | Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 1 (Tablet)
* Period 2: Dose Level 3 (Tablet)
* Period 3: 1 mg (Capsule)
* Period 4: Dose Level 2 (Tablet)
* Period 5: Dose Level 4 (Tablet)
* Period 6: Dose Level 6 (Tablet)
* Period 7: 3 mg (Capsule)
* Period 8: Dose Level 5 (Tablet)
* Period 9: Dose Level 7 (Tablet)
* Period 10: Dose Level 9 (Tablet)
* Period 11: 6 mg (Capsule)
* Period 12: Dose Level 8 (Tablet) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 1A, Sequence 4) | Experimental | Participants received LY3502970 orally QD across inpatient Treatment Periods 1-12 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: Dose Level 3 (Tablet)
* Period 2: Dose Level 1 (Tablet)
* Period 3: Dose Level 2 (Tablet)
* Period 4: 1 mg (Capsule)
* Period 5: Dose Level 6 (Tablet)
* Period 6: Dose Level 4 (Tablet)
* Period 7: Dose Level 5 (Tablet)
* Period 8: 3 mg (Capsule)
* Period 9: Dose Level 9 (Tablet)
* Period 10: Dose Level 7 (Tablet)
* Period 11: Dose Level 8 (Tablet)
* Period 12: 6 mg (Capsule) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 1) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule)
* Period 8: Dose Level 11 (Tablet)
* Period 9: Dose Level 10 (Tablet)
* Period 10: Dose Level 12 (Tablet)
* Period 11: 24 mg (Capsule)
* Period 12: Dose Level 14 (Tablet)
* Period 13: Dose Level 13 (Tablet)
* Period 14: Dose Level 16 (Tablet)
* Period 15: 36 mg (Capsule)
* Period 16: Dose Level 17 (Tablet)
* Period 17: Dose Level 15 (Tablet)
* Period 18: Dose Level 18 (Tablet) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 2) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 11 (Tablet)
* Period 8: 12 mg (Capsule)
* Period 9: Dose Level 12 (Tablet)
* Period 10: Dose Level 10 (Tablet)
* Period 11: Dose Level 14 (Tablet)
* Period 12: 24 mg (Capsule)
* Period 13: Dose Level 16 (Tablet)
* Period 14: Dose Level 13 (Tablet)
* Period 15: Dose Level 17 (Tablet)
* Period 16: 36 mg (Capsule)
* Period 17: Dose Level 18 (Tablet)
* Period 18: Dose Level 15 (Tablet) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 3) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 10 (Tablet)
* Period 8: Dose Level 12 (Tablet)
* Period 9: 12 mg (Capsule)
* Period 10: Dose Level 11 (Tablet)
* Period 11: Dose Level 13 (Tablet)
* Period 12: Dose Level 16 (Tablet)
* Period 13: 24 mg (Capsule)
* Period 14: Dose Level 14 (Tablet)
* Period 15: Dose Level 15 (Tablet)
* Period 16: Dose Level 18 (Tablet)
* Period 17: 36 mg (Capsule)
* Period 18: Dose Level 17 (Tablet) Receives: Drug: Orforglipron |
| Part A: LY3502970 Oral Administration (Cohort 2A, Sequence 4) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg; Capsule), followed by inpatient Treatment Periods 7-18 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: Dose Level 12 (Tablet)
* Period 8: Dose Level 10 (Tablet)
* Period 9: Dose Level 11 (Tablet)
* Period 10: 12 mg (Capsule)
* Period 11: Dose Level 16 (Tablet)
* Period 12: Dose Level 13 (Tablet)
* Period 13: Dose Level 14 (Tablet)
* Period 14: 24 mg (Capsule)
* Period 15: Dose Level 18 (Tablet)
* Period 16: Dose Level 15 (Tablet)
* Period 17: Dose Level 17 (Tablet)
* Period 18: 36 mg (Capsule) Receives: Drug: Orforglipron |
| Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 1) | Experimental | Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule- First Treatment)
* Period 2: 1 mg (Capsule- Second Treatment)
* Period 3: 0.8 mg (Tablet)
* Period 4: 3 mg (Capsule- First Treatment)
* Period 5: 3 mg (Capsule- Second Treatment)
* Period 6: 2.5 mg (Tablet)
* Period 7: 6 mg (Capsule- First Treatment)
* Period 8: 6 mg (Capsule- Second Treatment)
* Period 9: 5.5 mg (Tablet) Receives: Drug: Orforglipron |
| Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 2) | Experimental | Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 1 mg (Capsule- First Treatment)
* Period 2: 0.8 mg (Tablet)
* Period 3: 1 mg (Capsule- Second Treatment)
* Period 4: 3 mg (Capsule- First Treatment)
* Period 5: 2.5 mg (Tablet)
* Period 6: 3 mg (Capsule- Second Treatment)
* Period 7: 6 mg (Capsule- First Treatment)
* Period 8: 5.5 mg (Tablet)
* Period 9: 6 mg (Capsule- Second Treatment) Receives: Drug: Orforglipron |
| Part B: LY3502970 Oral Administration (Cohort 1B, Sequence 3) | Experimental | Participants received LY3502970 orally QD across inpatient Treatment Periods 1-9 (7 days per period), followed by a follow-up visit approximately 7 days after the last dose. Doses were administered as follows:
* Period 1: 0.8 mg (Tablet)
* Period 2: 1 mg (Capsule- First Treatment)
* Period 3: 1 mg (Capsule- Second Treatment)
* Period 4: 2.5 mg (Tablet)
* Period 5: 3 mg (Capsule- First Treatment)
* Period 6: 3 mg (Capsule- Second Treatment)
* Period 7: 5.5 mg (Tablet)
* Period 8: 6 mg (Capsule- First Treatment)
* Period 9: 6 mg (Capsule- Second Treatment) Receives: Drug: Orforglipron |
| Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 1) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg [Capsule]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule- First Treatment)
* Period 8: 12 mg (Capsule- Second Treatment)
* Period 9: 9 mg (Tablet)
* Period 10: 24 mg (Capsule- First Treatment)
* Period 11: 24 mg (Capsule- Second Treatment)
* Period 12: 14.5 mg (Tablet)
* Period 13: 36 mg (Capsule- First Treatment)
* Period 14: 36 mg (Capsule- Second Treatment)
* Period 15: 17.2 mg (Tablet) Receives: Drug: Orforglipron |
| Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 2) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg [Capsule]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 12 mg (Capsule- First Treatment)
* Period 8: 9 mg (Tablet)
* Period 9: 12 mg (Capsule- Second Treatment)
* Period 10: 24 mg (Capsule- First Treatment)
* Period 11: 14.5 mg (Tablet)
* Period 12: 24 mg (Capsule- Second Treatment)
* Period 13: 36 mg (Capsule- First Treatment)
* Period 14: 17.2 mg (Tablet)
* Period 15: 36 mg (Capsule- Second Treatment) Receives: Drug: Orforglipron |
| Part B: LY3502970 Oral Administration (Cohort 2B, Sequence 3) | Experimental | Participants received LY3502970 orally QD during home dosing Treatment Periods 1-6 (1 mg, 3 mg, and 6 mg [Capsule]), followed by inpatient Treatment Periods 7-15 (7 days per period) and a follow-up visit approximately 7 days after the last dose. Doses during inpatient periods were administered as follows:
* Period 7: 9 mg (Tablet)
* Period 8: 12 mg (Capsule- First Treatment)
* Period 9: 12 mg (Capsule- Second Treatment)
* Period 10: 14.5 mg (Tablet)
* Period 11: 24 mg (Capsule- First Treatment)
* Period 12: 24 mg (Capsule- Second Treatment)
* Period 13: 17.2 mg (Tablet)
* Period 14: 36 mg (Capsule- First Treatment)
* Period 15: 36 mg (Capsule- Second Treatment) Receives: Drug: Orforglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: Pharmacokinetics (PK): Steady-state Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau]) of LY3502970 on Day 7
PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC[0-tau] on Day 7.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7
PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state on Day 7.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
24 Jun 20242 Jun 2025
- First posted4 Jun 2024
- Study start24 Jun 2024
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 533 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
- NCT06440980
- Sponsor's protocol ID
- 18617
- Other IDs
- J2A-MC-GZPI
- Status last verified
- Jun 2026
- First submitted
- 29 May 2024
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma X, Li YG, Raha S, Sperry DC, Coutant DE, Bhattachar S. Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight. Diabetes Obes Metab. 2026 Jul;28(7):5803-5809. doi: 10.1111/dom.70783. Epub 2026 Apr 17.
PubMed 41994902