Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial.

Yabe D, Shiraiwa T, Ugai H, Takeuchi M, Suzuki R

The lancet. Diabetes & endocrinology17 Aug 2026Cited by 1 (Europe PMC)

PMID42607698DOI10.1016/s2213-8587(26)00138-5PepBankPUB-42607698

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study19

19 results from studies that gave the peptide. 19 results from people.

01HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 339 participants had at least one treatment-emergent adverse event with orforglipron.
In plain wordsIn Japanese adults with diabetes, 339 participants had an adverse event during orforglipron treatment.
Peptide
Orforglipron
Outcome
Not applicableAny treatment-emergent adverse event, pooled
Study
n = 401
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · oral · 52 weeksAs given in this study (human).
Measurements
TEAE
339 participants
all doses
TEAE
85%
all doses
95% confidence interval for TEAE percentage
80.7 to 87.8%
all doses
Source sentences
Summary
339 participants (85%, 95% CI 80·7-87·8) had at least one treatment-emergent adverse event (TEAE), more frequently in the 36-mg group (118 [88%, 95% CI 81·5-92·5]) than in the 3-mg (107 [81%, 73·5-86·8]) and 12-mg (114 [84%, 77·4-89·6]) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769802
02HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 267 participants had mild treatment-emergent adverse events with orforglipron.
In plain wordsIn Japanese adults with diabetes, 267 participants had mild adverse events during orforglipron treatment.
Peptide
Orforglipron
Outcome
Not applicableMild treatment-emergent adverse events
Study
n = 401
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · oral · 52 weeksAs given in this study (human).
Measurements
Mild TEAE
267 participants
all doses
Mild TEAE
67%
all doses
Confidence interval (level not stated) for mild TEAE percentage
61.8 to 71%
all doses
Source sentences
Summary
Most TEAEs were of mild (267 [67%, 61·8-71·0]) or moderate (63 [16%, 12·5-19·6]) severity.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769807
03HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 63 participants had moderate treatment-emergent adverse events with orforglipron.
In plain wordsIn Japanese adults with diabetes, 63 participants had moderate adverse events during orforglipron treatment.
Peptide
Orforglipron
Outcome
Not applicableModerate treatment-emergent adverse events
Study
n = 401
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · oral · 52 weeksAs given in this study (human).
Measurements
Moderate TEAE
63 participants
all doses
Moderate TEAE
16%
all doses
Confidence interval (level not stated) for moderate TEAE percentage
12.5 to 19.6%
all doses
Source sentences
Summary
Most TEAEs were of mild (267 [67%, 61·8-71·0]) or moderate (63 [16%, 12·5-19·6]) severity.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769808
04HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes receiving orforglipron, no severe hypoglycaemia events occurred.
In plain wordsIn Japanese adults with diabetes receiving orforglipron, no severe hypoglycaemia events occurred.
Peptide
Orforglipron
Outcome
Not applicableSevere hypoglycaemia
Study
n = 401
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
No level 3 (severe) hypoglycaemia events occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769818
05HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, treatment-emergent adverse events were more frequent with orforglipron 36 mg than 12 mg.
In plain wordsIn Japanese adults with diabetes, adverse events were more frequent with orforglipron 36 mg than 12 mg.
Peptide
Orforglipron
Outcome
IncreaseTreatment-emergent adverse events, 36 mg versus 12 mg
Study
n = 269
Comparator
Orforglipron 12 mg
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
36 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
TEAE
118 participants
36 mg
TEAE
88%
36 mg
TEAE
114 participants
12 mg
TEAE
84%
12 mg
95% confidence interval for TEAE percentage
81.5 to 92.5%
orforglipron 36 mg
95% confidence interval for TEAE percentage
77.4 to 89.6%
orforglipron 12 mg
Source sentences
Summary
339 participants (85%, 95% CI 80·7-87·8) had at least one treatment-emergent adverse event (TEAE), more frequently in the 36-mg group (118 [88%, 95% CI 81·5-92·5]) than in the 3-mg (107 [81%, 73·5-86·8]) and 12-mg (114 [84%, 77·4-89·6]) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769806
06HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, adverse-event discontinuations were 14% with orforglipron 36 mg versus 8% with 12 mg.
In plain wordsIn Japanese adults with diabetes, adverse-event discontinuations were higher with orforglipron 36 mg than 12 mg.
Peptide
Orforglipron
Outcome
IncreaseAdverse-event discontinuations, 36 mg versus 12 mg
Study
n = 269
Comparator
Orforglipron 12 mg
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
36 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuations
19 participants
36 mg
Discontinuations
14%
36 mg
Discontinuations
11 participants
12 mg
Discontinuations
8%
12 mg
95% confidence interval for adverse-event discontinuation percentage
9.3 to 21.1%
orforglipron 36 mg
95% confidence interval for adverse-event discontinuation percentage
4.6 to 14%
orforglipron 12 mg
Source sentences
Summary
Discontinuations due to an adverse event occurred in 19 of 134 participants (14%, 95% CI 9·3-21·1) in the 36-mg group compared with seven of 132 (5%, 2·6-10·5) in the 3-mg group and 11 of 135 (8%, 4·6-14·0) in the 12-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769812
07HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, treatment-emergent adverse events were more frequent with orforglipron 36 mg than 3 mg.
In plain wordsIn Japanese adults with diabetes, adverse events were more frequent with orforglipron 36 mg than 3 mg.
Peptide
Orforglipron
Outcome
IncreaseTreatment-emergent adverse events, 36 mg versus 3 mg
Study
n = 266
Comparator
Orforglipron 3 mg
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
36 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
TEAE
118 participants
36 mg
TEAE
88%
36 mg
TEAE
107 participants
3 mg
TEAE
81%
3 mg
95% confidence interval for TEAE percentage
81.5 to 92.5%
orforglipron 36 mg
95% confidence interval for TEAE percentage
73.5 to 86.8%
orforglipron 3 mg
Source sentences
Summary
339 participants (85%, 95% CI 80·7-87·8) had at least one treatment-emergent adverse event (TEAE), more frequently in the 36-mg group (118 [88%, 95% CI 81·5-92·5]) than in the 3-mg (107 [81%, 73·5-86·8]) and 12-mg (114 [84%, 77·4-89·6]) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769805
08HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, adverse-event discontinuations were 14% with orforglipron 36 mg versus 5% with 3 mg.
In plain wordsIn Japanese adults with diabetes, adverse-event discontinuations were higher with orforglipron 36 mg than 3 mg.
Peptide
Orforglipron
Outcome
IncreaseAdverse-event discontinuations, 36 mg versus 3 mg
Study
n = 266
Comparator
Orforglipron 3 mg
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
36 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuations
19 participants
36 mg
Discontinuations
14%
36 mg
Discontinuations
7 participants
3 mg
Discontinuations
5%
3 mg
95% confidence interval for adverse-event discontinuation percentage
9.3 to 21.1%
orforglipron 36 mg
95% confidence interval for adverse-event discontinuation percentage
2.6 to 10.5%
orforglipron 3 mg
Source sentences
Summary
Discontinuations due to an adverse event occurred in 19 of 134 participants (14%, 95% CI 9·3-21·1) in the 36-mg group compared with seven of 132 (5%, 2·6-10·5) in the 3-mg group and 11 of 135 (8%, 4·6-14·0) in the 12-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769811
09HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 114 participants receiving orforglipron 12 mg had treatment-emergent adverse events.
In plain wordsIn Japanese adults with diabetes, 114 participants receiving orforglipron 12 mg had adverse events during treatment.
Peptide
Orforglipron
Outcome
Not applicableTreatment-emergent adverse events, 12 mg
Study
n = 135
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
12 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
TEAE
114 participants
12 mg
TEAE
84%
12 mg
95% confidence interval for TEAE percentage
77.4 to 89.6%
orforglipron 12 mg
Source sentences
Summary
339 participants (85%, 95% CI 80·7-87·8) had at least one treatment-emergent adverse event (TEAE), more frequently in the 36-mg group (118 [88%, 95% CI 81·5-92·5]) than in the 3-mg (107 [81%, 73·5-86·8]) and 12-mg (114 [84%, 77·4-89·6]) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769804
10HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 11 participants discontinued orforglipron 12 mg because of adverse events.
In plain wordsIn Japanese adults with diabetes, 11 participants stopped orforglipron 12 mg because of adverse events.
Peptide
Orforglipron
Outcome
Not applicableAdverse-event discontinuations, 12 mg
Study
n = 135
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
12 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuations
11 participants
12 mg
Discontinuations
8%
12 mg
95% confidence interval for adverse-event discontinuation percentage
4.6 to 14%
orforglipron 12 mg
Source sentences
Summary
Discontinuations due to an adverse event occurred in 19 of 134 participants (14%, 95% CI 9·3-21·1) in the 36-mg group compared with seven of 132 (5%, 2·6-10·5) in the 3-mg group and 11 of 135 (8%, 4·6-14·0) in the 12-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769810
11HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, gastrointestinal symptoms caused eight discontinuations with orforglipron 12 mg.
In plain wordsIn Japanese adults with diabetes, gastrointestinal symptoms caused eight participants to stop orforglipron 12 mg.
Peptide
Orforglipron
Outcome
Not applicableGastrointestinal discontinuations, 12 mg
Study
n = 135
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
12 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Gastrointestinal discontinuations
8 participants
12 mg
Gastrointestinal discontinuations
5.9%
12 mg
Confidence interval (level not stated) for gastrointestinal discontinuation percentage
3 to 11.3%
orforglipron 12 mg
Source sentences
Summary
Across treatment groups, gastrointestinal symptoms were the most common TEAEs leading to study treatment discontinuation (3 mg: 5 [3·8%, 1·6-8·6]; 12 mg: 8 [5·9%, 3·0-11·3]; and 36 mg: 11 [8·2%, 4·7-14·1]).
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769814
12HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, three participants receiving orforglipron 12 mg had level 2 hypoglycaemia.
In plain wordsIn Japanese adults with diabetes, three participants receiving orforglipron 12 mg had level 2 hypoglycaemia.
Peptide
Orforglipron
Outcome
Not applicableLevel 2 hypoglycaemia, 12 mg
Study
n = 135
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
12 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Level 2 hypoglycaemia
3 participants
12 mg
Level 2 hypoglycaemia
2%
12 mg
Confidence interval (level not stated) for level 2 hypoglycaemia percentage
0.8 to 6.3%
orforglipron 12 mg
Source sentences
Summary
Level 2 (blood glucose <54 mg/dL) hypoglycaemia events occurred in three of 135 participants in the 12-mg group (2%, 0·8-6·3) and in three of 134 in the 36-mg group (2%, 0·8-6·4) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769816
13HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, gastrointestinal symptoms caused 11 discontinuations with orforglipron 36 mg.
In plain wordsIn Japanese adults with diabetes, gastrointestinal symptoms caused 11 participants to stop orforglipron 36 mg.
Peptide
Orforglipron
Outcome
Not applicableGastrointestinal discontinuations, 36 mg
Study
n = 134
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
36 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Gastrointestinal discontinuations
11 participants
36 mg
Gastrointestinal discontinuations
8.2%
36 mg
Confidence interval (level not stated) for gastrointestinal discontinuation percentage
4.7 to 14.1%
orforglipron 36 mg
Source sentences
Summary
Across treatment groups, gastrointestinal symptoms were the most common TEAEs leading to study treatment discontinuation (3 mg: 5 [3·8%, 1·6-8·6]; 12 mg: 8 [5·9%, 3·0-11·3]; and 36 mg: 11 [8·2%, 4·7-14·1]).
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769815
14HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, three participants receiving orforglipron 36 mg had level 2 hypoglycaemia.
In plain wordsIn Japanese adults with diabetes, three participants receiving orforglipron 36 mg had level 2 hypoglycaemia.
Peptide
Orforglipron
Outcome
Not applicableLevel 2 hypoglycaemia, 36 mg
Study
n = 134
Analysis
Primary
Outcome group
Adverse events · Metabolic and weight
Studied dose
36 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Level 2 hypoglycaemia
3 participants
36 mg
Level 2 hypoglycaemia
2%
36 mg
Confidence interval (level not stated) for level 2 hypoglycaemia percentage
0.8 to 6.4%
orforglipron 36 mg
Source sentences
Summary
Level 2 (blood glucose <54 mg/dL) hypoglycaemia events occurred in three of 135 participants in the 12-mg group (2%, 0·8-6·3) and in three of 134 in the 36-mg group (2%, 0·8-6·4) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769817
15HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, 107 participants receiving orforglipron 3 mg had treatment-emergent adverse events.
In plain wordsIn Japanese adults with diabetes, 107 participants receiving orforglipron 3 mg had adverse events during treatment.
Peptide
Orforglipron
Outcome
Not applicableTreatment-emergent adverse events, 3 mg
Study
n = 132
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
3 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
TEAE
107 participants
3 mg
TEAE
81%
3 mg
95% confidence interval for TEAE percentage
73.5 to 86.8%
orforglipron 3 mg
Source sentences
Summary
339 participants (85%, 95% CI 80·7-87·8) had at least one treatment-emergent adverse event (TEAE), more frequently in the 36-mg group (118 [88%, 95% CI 81·5-92·5]) than in the 3-mg (107 [81%, 73·5-86·8]) and 12-mg (114 [84%, 77·4-89·6]) groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769803
16HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, seven participants discontinued orforglipron 3 mg because of adverse events.
In plain wordsIn Japanese adults with diabetes, seven participants stopped orforglipron 3 mg because of adverse events.
Peptide
Orforglipron
Outcome
Not applicableAdverse-event discontinuations, 3 mg
Study
n = 132
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
3 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Discontinuations
7 participants
3 mg
Discontinuations
5%
3 mg
95% confidence interval for adverse-event discontinuation percentage
2.6 to 10.5%
orforglipron 3 mg
Source sentences
Summary
Discontinuations due to an adverse event occurred in 19 of 134 participants (14%, 95% CI 9·3-21·1) in the 36-mg group compared with seven of 132 (5%, 2·6-10·5) in the 3-mg group and 11 of 135 (8%, 4·6-14·0) in the 12-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769809
17HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes, gastrointestinal symptoms caused five discontinuations with orforglipron 3 mg.
In plain wordsIn Japanese adults with diabetes, gastrointestinal symptoms caused five participants to stop orforglipron 3 mg.
Peptide
Orforglipron
Outcome
Not applicableGastrointestinal discontinuations, 3 mg
Study
n = 132
Analysis
Primary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg once daily · oral · 52 weeksAs given in this study (human).
Measurements
Gastrointestinal discontinuations
5 participants
3 mg
Gastrointestinal discontinuations
3.8%
3 mg
Confidence interval (level not stated) for gastrointestinal discontinuation percentage
1.6 to 8.6%
orforglipron 3 mg
Source sentences
Summary
Across treatment groups, gastrointestinal symptoms were the most common TEAEs leading to study treatment discontinuation (3 mg: 5 [3·8%, 1·6-8·6]; 12 mg: 8 [5·9%, 3·0-11·3]; and 36 mg: 11 [8·2%, 4·7-14·1]).
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769813
18HumanRandomized controlled trialOther
In Japanese adults with diabetes, 352 participants completed orforglipron treatment.
In plain wordsIn Japanese adults with diabetes, 352 participants completed orforglipron treatment.
Peptide
Orforglipron
Outcome
Not applicableTreatment completion
Study
n = 401
Outcome group
Treatment adherence and retention · Whole body
Studied dose
Dose not stated · oral · 52 weeksAs given in this study (human).
Measurements
Completed treatment
352 participants
all doses
Completion
88%
all doses
Source sentences
Summary
352 (88%) completed study treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
Between Sept 28, 2023, and June 5, 2025, 450 participants were screened and 401 were randomly assigned to three groups (3 mg, n=132; 12 mg, n=135; and 36 mg, n=134).
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769801
19HumanRandomized controlled trialSafety outcome
In Japanese adults with diabetes receiving orforglipron, outcomes were generally similar across background therapies.
In plain wordsIn Japanese adults with diabetes receiving orforglipron, outcomes were generally similar across background therapies.
Peptide
Orforglipron
Outcome
Direction not reportedOutcomes across background therapies
Study
n = 401
Comparator
Other background therapies
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · oral · 52 weeksAs given in this study (human).
Source sentences
Summary
Outcomes were generally similar across background therapies.
2 context sentences(design, population, supporting numbers)
Summary · context
This multicentre, randomised, open-label phase 3 study was conducted in 40 medical research centres and hospitals in Japan.
Summary · context
The primary endpoint was safety for 52 weeks, assessed in all randomly assigned participants who received at least one dose of orforglipron.
Report a problemFND-4260769819

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT06010004

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Eli Lilly and Companyn = 40128 Sept 2023 to 5 Jun 2025

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 30 Jun 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

Terms as the source lists them.

Publication types

MeSH terms

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