GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

142

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI ≥18.5•Healthy volunteers

Primary endpoint

•Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02759107

Org study ID16119

Secondary IDI8F-MC-GPGAEli Lilly and Company

Timeline

Milestones

Study first posted2016-05-03estimated

Study start2016-05-11actual

Primary completion2017-06-26actual

Study completion2017-06-26actual

Last update posted2024-01-16actual

Results first posted2024-01-16actual

Assets

Investigational agents

Dulaglutide Tirzepatide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C)

•Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive

•Participants with T2DM (Part C only): have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). Participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug

Exclusion criteria

•Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds

•Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study

•Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors

Participants with T2DM (Part C only)

•Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

All Study Participants (Parts B and C only)

•have known allergies to tirzepatide, GLP-1 analogs, or related compounds, or acetaminophen

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

4 endpoints

Secondary/registry result

Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)

Time frame:Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2

Postprandial glucose

ratio, improvement

Posted result

Group	Value (geometric_least_squares_mean), ratio	95% CI
Part C - 0.5mg Tirzepatide	0.99	0.79 – 1.11
Part C - 5mg Tirzepatide	0.72	0.58 – 0.81
Part C - 5, 5, 10,10mg Tirzepatide	0.65	0.53 – 0.73
Part C - 5, 5, 10,15mg Tirzepatide	0.73	0.59 – 0.81

Secondary/registry result

Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)

Time frame:Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

Postprandial glucose

ratio, improvement

Posted result

Group	Value (geometric_least_squares_mean), ratio	95% CI
Part C - 0.5mg Tirzepatide	0.96	0.83 – 1.16
Part C - 5mg Tirzepatide	0.61	0.52 – 0.75
Part C - 5, 5, 10,10mg Tirzepatide	0.58	0.51 – 0.70
Part C - 5, 5, 10,15mg Tirzepatide	0.57	0.50 – 0.69

Secondary/protocol endpoint

Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)

Time frame:Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2

Postprandial glucose

ratio, improvement

Secondary/protocol endpoint

Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)

Time frame:Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

Postprandial glucose

ratio, improvement

Safety / tolerability / PK

8 endpoints

Primary/registry result

Number of Participants With One or More Serious Adverse Event(s) (SAEs)

Time frame:Baseline through Day 43 (Part A) and Day 57 (Part B and C)

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Participants	95% CI
Tirzepatide (Part A)	0	—
Placebo (Part A)	0	—
Tirzepatide (Part B)	0	—
Placebo (Part B)	0	—
Dulaglutide (Part B)	1	—
Tirzepatide (Part C)	0	—
Placebo (Part C)	0	—

Primary/protocol endpoint

Number of Participants With One or More Serious Adverse Event(s) (SAEs)

Time frame:Baseline through Day 43 (Part A) and Day 57 (Part B and C)

Serious AEs (any)

event count, event

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.

Time frame:Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), Hour * nanogram per milliliter (h*ng/mL)	95% CI
Part A - 0.25mg Tirzepatide	5760	—
Part A - 0.5mg Tirzepatide	12000	—
Part A - 1mg Tirzepatide	22600	—
Part A - 2.5mg Tirzepatide	53200	—
Part A - 5mg Tirzepatide	90500	—
Part A - 8mg Tirzepatide	169000	—

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B

Time frame:Predose, 8hours(h), 24h,48h,72h,168h postdose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), Hour * nanogram per milliliter (h*ng/mL)	95% CI
Part B - 0.5mg Tirzepatide	6000	—
Part B - 1.5mg Tirzepatide	16300	—
Part B - 4.5mg Tirzepatide	53300	—
Part B - 5, 5, 8,10mg Tirzepatide	56900	—

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C

Time frame:Predose, 8hours(h), 24h,48h,72h,168h postdose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), Hour * nanogram per milliliter (h*ng/mL)	95% CI
Part C - 0.5mg Tirzepatide	4770	—
Part C - 5mg Tirzepatide	50500	—
Part C - 5, 5, 10,10mg Tirzepatide	41900	—
Part C - 5, 5, 10,15mg Tirzepatide	37990	—

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.

Time frame:Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B

Time frame:Predose, 8hours(h), 24h,48h,72h,168h postdose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C

Time frame:Predose, 8hours(h), 24h,48h,72h,168h postdose

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept.
Molecular metabolism2018 Dec (month)PMID30473097doi:10.1016/j.molmet.2018.09.009via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.