FDA drug record/Obesity and weight management/Trulicity

FDA record · Obesity and weight management

Trulicity (dulaglutide)

What FDA's own documents say about Trulicity: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.

Sponsor
Eli Lilly and Co.
Application
BLA 125469
First approved
September 18, 2014
Status
Approved
Read from
47 FDA documents, 1,993 pages

What it is approved for

“TRULICITY® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated (1):”

Prescribing information, supplement 065 · PDF p. 1 · fda.gov ↗

Trials FDA reviewed

TrialClinicalTrials.govPhaseMentionsDocuments
TRULICITY 013798NCT01621178378614 of 47
TRULICITY 1not given77814 of 47
H9X-MC-GBCFNCT007344742/3457 of 47
H9X-MC-GBDCNCT011265803285 of 47
AWARD-1H9X-MC-GBDANCT010646873256 of 47
H9X-MC-GBDDNCT011912683254 of 47
AWARD-2H9X-MC-GBDBNCT010752823175 of 47
Study GBCTnot given81 of 47
H9X-MC-GBDRNCT01301092152 of 47
Study GBCBnot given41 of 47
H9X-MC-GBDTNCT01524770142 of 47
Study GBCAnot given31 of 47

Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.

Results FDA reported

Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.

HbA1c

“At week 52, dulaglutide 1.5 mg resulted in a statistically significant reduction in mean HbA1c compared to metformin; the estimated increased reduction was 0.19% with 95% CI (-0.35, -”

Statistical Review · PDF p. 67 · fda.gov ↗

reduction was 0.1995%

HbA1c

“At week 52, dulaglutide 1.5 mg resulted in a statistically significant reduction in mean HbA1c change compared to insulin glargine (diff = -0.45%; 95% CI = -0.60, -0.29).”

Statistical Review · PDF p. 83 · fda.gov ↗

95%change compared to insulin glargine (diff = -0.45

MACE

“MACE+ was 0.56 with 95% CI (0.29, 1.11).”

Statistical Review · PDF p. 8 · fda.gov ↗

95% CI (0.29, 1.11)

MACE

“For the 0.75 mg dose, the HR estimate of MACE+ was 0.56 with 95% CI (0.29, 1.11).”

Statistical Review · PDF p. 34 · fda.gov ↗

95% CI (0.29, 1.11)

Safety

Most common adverse reactions

“Most common adverse reactions (incidence >=5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite (6.1).”

Prescribing information, supplement 065 · PDF p. 1 · fda.gov ↗

Adverse events the documents discuss most

Dosing on the label

“• Maximum recommended dosage is 4.5 mg injected subcutaneously once weekly.”

Prescribing information, supplement 065 · PDF p. 1 · fda.gov ↗

“• If additional glycemic control is needed, increase dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage.”

Prescribing information, supplement 065 · PDF p. 1 · fda.gov ↗

FDA documents read

DocumentDatePagesCopysha256
Approval letter125469Orig1s000ltr.pdfSeptember 19, 201414c78aa6e5ac7b
Administrative Correspondence125469Orig1s000AdminCorres.pdfOctober 27, 2014201740abc5e5016
Approval Letter125469Orig1s000Approv.pdfOctober 27, 201415f69c6b3a2d62
Chemistry Review125469Orig1s000ChemR.pdfOctober 27, 2014481ca8a7de32f5
Clinical Pharmacology Review125469Orig1s000ClinPharmR.pdfOctober 27, 20141167700d03a83e8
Cross Discipline Team Leader Review125469Orig1s000CrossR.pdfOctober 27, 2014493b1f338808ba
Microbiology Review125469Orig1s000MicroR.pdfOctober 27, 201426cb0122787dc6
Proprietary Name Review125469Orig1s000NameR.pdfOctober 27, 2014292cd97003f459
Office Director Memorandum125469Orig1s000ODMemo.pdfOctober 27, 2014101925a9c52c06
Officer/Employee List125469Orig1s000OEList.pdfOctober 27, 20142a7b945b0130b
Other Reviews125469Orig1s000OtherR.pdfOctober 27, 20142206cff0d96ab51
Pharmacology/Toxicology Review125469Orig1s000PharmR.pdfOctober 27, 2014245e0039f10cf2f
REMS125469Orig1s000REMS.pdfOctober 27, 201416f2968b1ab027
Risk Assessment / REMS Review125469Orig1s000RiskR.pdfOctober 27, 201448f93da929688e
Statistical Review125469Orig1s000StatR.pdfOctober 27, 2014128c1b3da0bb076
Summary Review125469Orig1s000SumR.pdfOctober 27, 201416282ea41bc16c
Approval letter, supplement 002125469Orig1s002ltr.pdfDecember 24, 20144169ccf11661f
Approval letter, supplement 001125469Orig1s001ltr.pdfMarch 11, 2015410c6b753173d
Prescribing Information (Label)125469Orig1s000Lbl.pdfApril 1, 201562c258b3ed79a5
Approval letter, supplement 004125469Orig1s004ltr.pdfJuly 28, 20156archived copy36bc16ed0a9b
Prescribing information, supplements 007 and 008125469s007s008lbl.pdfJanuary 27, 201751cf5402a741ca
Approval letter, supplements 007 and 008125469Orig1s007_s008ltr.pdfJanuary 31, 20174archived copydfc7252cb9d3
125469Orig1s013ltr, supplement 011125469Orig1s011_125469Orig1s013ltr.pdfAugust 2, 201748df11c1890c2
Prescribing information, supplements 011 and 013125469s011s013lbl.pdfAugust 4, 201751418ccb84ac05
Approval letter, supplement 021125469Orig1s021ltr.pdfDecember 18, 2017345a6c55a8b71
Approval letter, supplement 017125469Orig1s017ltr.pdfJuly 6, 201840b7e02040687
Prescribing information, supplement 017125469s017lbl.pdfJuly 13, 2018522a543fe00bfb
Approval letter, supplement 024125469Orig1s024ltr.pdfOctober 1, 2018407ea4d64bc2c
Prescribing information, supplement 024125469s024lbl.pdfOctober 15, 201850475646914a3b
Prescribing information, supplement 023125469s023lbl.pdfJanuary 16, 2019379776f640aa30
Approval letter, supplement 023125469Orig1s023ltr.pdfJanuary 18, 20194e0cefb927280
Prescribing information, supplement 033125469s033lbl.pdfFebruary 24, 20204045163b3b9e2d
Approval letter, supplement 033125469Orig1s033ltr.pdfFebruary 25, 20205a7f04c3cb54e
Approval letter, supplement 036125469Orig1s036ltr.pdfSeptember 4, 2020518719af9f6db
Prescribing information, supplement 036125469s036lbl.pdfSeptember 8, 2020531d59977c3c97
Prescribing information, supplement 044125469s044lbl.pdfOctober 1, 20215360187c5a3efc
Approval letter, supplement 044125469Orig1s044ltr.pdfOctober 4, 202147ad43acc4ec7
Approval letter, supplements 046 and 052125469Orig1s046_s052ltr.pdfJune 13, 2022535a32ae65f87
Prescribing information, supplements 046 and 052125469s046s052lbl.pdfJune 15, 202253bc70a35fdd5a
Approval letter, supplement 051125469Orig1s051ltr.pdfNovember 18, 20225021b2a0acee9
Prescribing information, supplement 051125469s051lbl.pdfNovember 21, 202258657d9e7d1c61
Prescribing information, supplements 061 and 062125469s061s062lbl.pdfNovember 4, 202458c2d7c9cef63b
Approval letter, supplements 061 and 062125469Orig1s061_s062ltr.pdfNovember 5, 202458fecfad5ccf0
Approval letter, supplement 063125469Orig1s063ltr.pdfMay 29, 2025562ad4531f92a
Prescribing information, supplement 063125469s063lbl.pdfJune 2, 2025587d5952a5099c
Approval letter, supplement 065125469Orig1s065ltr.pdfMarch 16, 2026538def2b5c67b
Prescribing information, supplement 065125469s065lbl.pdfMarch 18, 202658b9c901e50f58

Checked against FDA's copies on September 29, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.

Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.

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