Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist.

Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW

Diabetes therapy : research, treatment and education of diabetes and related disorders24 Feb 2024Cited by 22 (Europe PMC)

PMID38402332PMCIDPMC10951152DOI10.1007/s13300-024-01554-1PepBankPUB-38402332

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialPharmacokinetics
In healthy adults in study B, orforglipron AUC was 17.6% lower in the fed than fasted state.
In plain wordsOrforglipron exposure was 17.6% lower with food than without food in healthy adults in study B.
Peptide
Orforglipron
Outcome
DecreaseAUC study B
Study
n = 34
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
16 mg multiple doses · oralAs given in this study (human).
Measurements
AUC difference, fed vs fasted
−17.6%
study B, GLSM, fed vs fasted
Source sentences
Summary
GLSM AUC and C_max were lower by 23.7% and 23.2% in study A, and 17.6% and 20.9% in study B, in the fed versus fasted states, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233203
02HumanRandomized controlled trialPharmacokinetics
In healthy adults in study B, orforglipron maximum concentration was 20.9% lower in the fed than fasted state.
In plain wordsOrforglipron peak concentration was 20.9% lower with food than without food in healthy adults in study B.
Peptide
Orforglipron
Outcome
DecreaseMaximum concentration study B
Study
n = 34
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
16 mg multiple doses · oralAs given in this study (human).
Measurements
Cmax difference, fed vs fasted
−20.9%
study B, GLSM, fed vs fasted
Source sentences
Summary
GLSM AUC and C_max were lower by 23.7% and 23.2% in study A, and 17.6% and 20.9% in study B, in the fed versus fasted states, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233204
03HumanRandomized controlled trialPharmacokinetics
In healthy adults in study B, orforglipron half-life was comparable between fed and fasted states.
In plain wordsOrforglipron half-life was similar with and without food in healthy adults in study B.
Peptide
Orforglipron
Outcome
No significant changeHalf-life study B
Study
n = 34
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
16 mg multiple doses · oralAs given in this study (human).
Source sentences
Summary
In both studies, t_1/2 and median t_max were comparable between fed and fasted states.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233206
04HumanRandomized controlled trialPharmacokinetics
In healthy adults in study B, median time to maximum orforglipron concentration was comparable between fed and fasted states.
In plain wordsOrforglipron reached its peak concentration at similar times with and without food in healthy adults in study B.
Peptide
Orforglipron
Outcome
No significant changeTime to maximum concentration study B
Study
n = 34
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
16 mg multiple doses · oralAs given in this study (human).
Source sentences
Summary
In both studies, t_1/2 and median t_max were comparable between fed and fasted states.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233208
05HumanRandomized controlled trialPharmacokinetics
In healthy adults in study A, orforglipron AUC was 23.7% lower in the fed than fasted state.
In plain wordsOrforglipron exposure was 23.7% lower with food than without food in healthy adults in study A.
Peptide
Orforglipron
Outcome
DecreaseAUC study A
Study
n = 12
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3 mg single dose · oralAs given in this study (human).
Measurements
AUC difference, fed vs fasted
−23.7%
study A, GLSM, fed vs fasted
Source sentences
Summary
GLSM AUC and C_max were lower by 23.7% and 23.2% in study A, and 17.6% and 20.9% in study B, in the fed versus fasted states, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233201
06HumanRandomized controlled trialPharmacokinetics
In healthy adults in study A, orforglipron maximum concentration was 23.2% lower in the fed than fasted state.
In plain wordsOrforglipron peak concentration was 23.2% lower with food than without food in healthy adults in study A.
Peptide
Orforglipron
Outcome
DecreaseMaximum concentration study A
Study
n = 12
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3 mg single dose · oralAs given in this study (human).
Measurements
Cmax difference, fed vs fasted
−23.2%
study A, GLSM, fed vs fasted
Source sentences
Summary
GLSM AUC and C_max were lower by 23.7% and 23.2% in study A, and 17.6% and 20.9% in study B, in the fed versus fasted states, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233202
07HumanRandomized controlled trialPharmacokinetics
In healthy adults in study A, orforglipron half-life was comparable between fed and fasted states.
In plain wordsOrforglipron half-life was similar with and without food in healthy adults in study A.
Peptide
Orforglipron
Outcome
No significant changeHalf-life study A
Study
n = 12
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3 mg single dose · oralAs given in this study (human).
Source sentences
Summary
In both studies, t_1/2 and median t_max were comparable between fed and fasted states.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233205
08HumanRandomized controlled trialPharmacokinetics
In healthy adults in study A, median time to maximum orforglipron concentration was comparable between fed and fasted states.
In plain wordsOrforglipron reached its peak concentration at similar times with and without food in healthy adults in study A.
Peptide
Orforglipron
Outcome
No significant changeTime to maximum concentration study A
Study
n = 12
Comparator
Fasted state
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
3 mg single dose · oralAs given in this study (human).
Source sentences
Summary
In both studies, t_1/2 and median t_max were comparable between fed and fasted states.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233207
09HumanRandomized controlled trialSafety outcome
In healthy adults, most treatment-emergent adverse events in both orforglipron studies were gastrointestinal conditions.
In plain wordsMost new adverse events in both orforglipron studies were digestive conditions in healthy adults.
Peptide
Orforglipron
Outcome
Not applicableGastrointestinal treatment-emergent adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg single dose (study A); 16 mg multiple doses (study B) · oralAs given in this study (human).
Source sentences
Summary
The majority of TEAEs in both studies were gastrointestinal tract-related conditions.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233209
10HumanRandomized controlled trialSafety outcome
In healthy adults, neither orforglipron study reported serious adverse events.
In plain wordsNeither orforglipron study reported serious adverse events in healthy adults.
Peptide
Orforglipron
Outcome
Not applicableSerious adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
3 mg single dose (study A); 16 mg multiple doses (study B) · oralAs given in this study (human).
Source sentences
Summary
No serious adverse events or deaths were reported in either study.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233210
11HumanRandomized controlled trialSafety outcome
In healthy adults, neither orforglipron study reported deaths.
In plain wordsNeither orforglipron study reported deaths in healthy adults.
Peptide
Orforglipron
Outcome
Not applicableDeaths
Study
n: not reported in source
Outcome group
Mortality · Whole body
Studied dose
3 mg single dose (study A); 16 mg multiple doses (study B) · oralAs given in this study (human).
Source sentences
Summary
No serious adverse events or deaths were reported in either study.
2 context sentences(design, population, supporting numbers)
Summary · context
Study A and study B were phase 1, randomized, crossover studies in healthy adults aged 18-65 years and 21-70 years, respectively.
Summary · context
Participants received single (3 mg, study A) or multiple (16 mg, study B) oral doses of orforglipron under fasted and fed conditions.
Report a problemFND-3840233211

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1Results postedNCT05110794

A Multiple-Dose Study of LY3502970 in Healthy Participants

Eli Lilly and Companyn = 345 Nov 2021 to 10 Feb 2022

Healthy

Trial page ClinicalTrials.govUpdated 26 May 2026

CompletedPhase 1Results postedNCT03929744

A Study of LY3502970 in Healthy Participants

Eli Lilly and Companyn = 13312 Jun 2019 to 2 Nov 2020

Healthy

Trial page ClinicalTrials.govUpdated 10 Jul 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

Subjects

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