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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT02759107 (opens ClinicalTrials.gov in a new tab)Other id16119Other idI8F-MC-GPGA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
142 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Singapore

Start
11 May 2016
Primary completion
26 Jun 2017
Completion
26 Jun 2017
First posted
3 May 2016 (estimated)
Last update posted
16 Jan 2024
Conditions
Healthy · Type 2 Diabetes Mellitus (T2DM)

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 1

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

    NCT02759107

    11 May 2016 to 26 Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purposes of this study are to determine: * The safety of tirzepatide and any side effects that might be associated with it. * How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it. * How tirzepatide affects the levels of blood sugar. This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in duration, including screening. Each participant will enroll in only one part. This study is for research purposes only, and is not intended to treat any medical condition.

Interventions

  • TirzepatideDrug
  • PlaceboDrug
  • DulaglutideDrug

Arms7

  • Experimental

    Tirzepatide (Part A)

    Participants received escalating single doses of either 0.25 milligram (mg) or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide by subcutaneous injection.

  • Placebo comparator

    Placebo (Part A)

    Participants received single dose of placebo by subcutaneous injection.

  • Experimental

    Tirzepatide (Part B)

    Participants received fixed doses of either 0.5mg or 1.5mg or 4.5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg, 5mg, 8mg and 10mg Tirzepatide once weekly for four weeks by subcutaneous injection.

  • Placebo comparator

    Placebo (Part B)

    Participants received placebo once weekly for four weeks by subcutaneous injection.

  • Active comparator

    Dulaglutide (Part B)

    Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.

  • Experimental

    Tirzepatide (Part C)

    Participants received fixed doses of either 0.5mg or 5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection

  • Placebo comparator

    Placebo (Part C)

    Participants received placebo once weekly for four weeks by subcutaneous injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module

Secondary outcomes(5)

  1. 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

    Registry description

    Area under the concentration versus time curve from zero to infinity (AUC \[0-∞\]) of Tirzepatide in Part A.

  2. 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

    Registry description

    Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part B. τ equals 168 hours.

  3. 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

    Registry description

    Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part C. τ equals 168 hours.

  4. 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

    Registry description

    PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\[0-2h\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).

  5. 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

    Registry description

    PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\[0-2h\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline through Day 43 (Part A) and Day 57 (Part B and C)

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

GroupValue (Participants)
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
Secondary and other outcome results(5)
Secondary outcomeGeometric mean· Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43

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

GroupValue (Hour * nanogram per milliliter (h*ng/mL))Spread
Part A - 0.25mg Tirzepatide576022
Part A - 0.5mg Tirzepatide1200024
Part A - 1mg Tirzepatide2260014
Part A - 2.5mg Tirzepatide5320036
Part A - 5mg Tirzepatide9050015
Part A - 8mg Tirzepatide1690008
Secondary outcomeGeometric mean· Predose, 8hours(h), 24h,48h,72h,168h postdose

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

GroupValue (Hour * nanogram per milliliter (h*ng/mL))Spread
Part B - 0.5mg Tirzepatide600023
Part B - 1.5mg Tirzepatide1630013
Part B - 4.5mg Tirzepatide5330019
Part B - 5, 5, 8,10mg Tirzepatide5690010
Secondary outcomeGeometric mean· Predose, 8hours(h), 24h,48h,72h,168h postdose

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

GroupValue (Hour * nanogram per milliliter (h*ng/mL))Spread
Part C - 0.5mg Tirzepatide477030
Part C - 5mg Tirzepatide5050020
Part C - 5, 5, 10,10mg Tirzepatide4190026
Part C - 5, 5, 10,15mg Tirzepatide3799021
Secondary outcomeGeometric least squares mean· Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2

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

GroupValue (ratio)
Part C - 0.5mg Tirzepatide0.99
Part C - 5mg Tirzepatide0.72
Part C - 5, 5, 10,10mg Tirzepatide0.65
Part C - 5, 5, 10,15mg Tirzepatide0.73
Secondary outcomeGeometric least squares mean· Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

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

GroupValue (ratio)
Part C - 0.5mg Tirzepatide0.96
Part C - 5mg Tirzepatide0.61
Part C - 5, 5, 10,10mg Tirzepatide0.58
Part C - 5, 5, 10,15mg Tirzepatide0.57

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part A - PlaceboParticipants received placebo by subcutaneous (SC) injection.0 / 140 / 147 / 14
Part A - 0.25mg TirzepatideParticipants received 0.25mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 60 / 64 / 6
Part A - 0.5mg TirzepatideParticipants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 120 / 1210 / 12
Part A - 1mg TirzepatideParticipants received 1mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 50 / 53 / 5
Part A - 2.5mg TirzepatideParticipants received 2.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 60 / 62 / 6
Part A - 5mg TirzepatideParticipants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 60 / 66 / 6
Part A - 8mg TirzepatideParticipants received 8mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 70 / 77 / 7
Part B - PlaceboParticipants received placebo by subcutaneous injection.0 / 40 / 43 / 4
Part B - 1.5mg DulaglutideParticipants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.0 / 41 / 43 / 4
Part B - 0.5mg TirzepatideParticipants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 60 / 66 / 6
Part B - 1.5mg TirzepatideParticipants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 60 / 65 / 6
Part B - 4.5mg TirzepatideParticipants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections.0 / 60 / 66 / 6
Part B - 5, 5, 8,10mg TirzepatideParticipants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 8mg QW followed by 10mg QW.0 / 70 / 76 / 7
Part C - PlaceboParticipants received placebo by subcutaneous injection.0 / 110 / 113 / 11
Part C - 0.5mg TirzepatideParticipants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 90 / 95 / 9
Part C - 5mg TirzepatideParticipants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection.0 / 90 / 97 / 9
Part C - 5, 5, 10,10mg TirzepatideParticipants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 10mg QW.0 / 120 / 1210 / 12
Part C - 5, 5, 10,15mg TirzepatideParticipants received titrated doses of Tirzepatide once a week for four weeks by subcutaneous injection. 5mg QW followed by 5mg QW followed by 10mg QW followed by 15mg QW.0 / 120 / 1211 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

10 results

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.

Coskun et al. 2018Molecular metabolismcited by 700

PMID 30473097PMC6308032DOI 10.1016/j.molmet.2018.09.009PUB-30473097

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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