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> Record changed: 2026-10-13

# A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

NCT06440980

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

Participants

533

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

Lead sponsor

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

Start date

2024-06-24

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

Number of sites

7

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Title and summary

**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. 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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Short title**

A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Registry reports results**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Dates

**Completion date**

2025-06-02

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**First posted**

2024-06-04

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Registry last updated**

2026-07-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Primary completion date**

2025-06-02

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Start date**

2024-06-24

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Size and sites

**Actual participants**

533

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Participants**

533

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Protocol amendments**

5

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Number of sites**

7

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Lead sponsor**

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Identifiers

**Registry ID**

NCT06440980

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**ClinicalTrials.gov ID**

NCT06440980

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Basic science

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Outcomes

### Primary outcomes

1. 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  
Timeframe: 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)  
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.
2. Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7  
Timeframe: 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)  
PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state on Day 7.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

65 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- 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.

### Exclusion criteria

- 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)
- 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Sites

- Anaheim Clinical Trials, LLCAnaheim, United States
- Collaborative Neuroscience Research, LLCLos Alamitos, United States
- Fortrea Clinical Research UnitDaytona Beach, United States
- Altasciences Company Inc.Overland Park, United States
- QPSSpringfield, United States
- Fortrea Clinical Research UnitDallas, United States
- Fortrea Clinical Research UnitMadison, United States

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## References

- PubMed 41994902  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41994902/)
Related publication

- Related resource (trials.lilly.com)  
Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/495475)

### Other registry identifiers

- J2A-MC-GZPI

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440980)

## Related records

### Drugs (1)

- [Orforglipron](https://trialight.com/data/asset/orforglipron-1138c12b-f1c7-45bb-b9ec-2b693f019a62.md)

### Lead sponsors (1)

- [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md)

### Conditions (1)

- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md)

---

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