Healthy, Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
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
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
DRUGDulaglutide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) | Baseline through Day 43 (Part A) and Day 57 (Part B and C) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43 | Area under the concentration versus time curve from zero to infinity (AUC \[0-∞\]) of Tirzepatide in Part A. |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B | Predose, 8hours(h), 24h,48h,72h,168h postdose | Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part B. τ equals 168 hours. |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C | Predose, 8hours(h), 24h,48h,72h,168h postdose | Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part C. τ equals 168 hours. |
| Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C) | Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2 | 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). |
| Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C) | Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23 | 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). |
Countries
Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A Placebo Participants received placebo by subcutaneous (SC) injection. | 14 |
| Part A 0.25 mg Tirzepatide Participants received single dose of 0.25mg Tirzepatide by subcutaneous injection. | 6 |
| Part A 0.5mg Tirzepatide Participants received single dose of 0.5mg Tirzepatide by subcutaneous injection. | 12 |
| Part A 1mg Tirzepatide Participants received single dose of 1mg Tirzepatide by subcutaneous injection. | 5 |
| Part A 2.5mg Tirzepatide Participants received single dose of 2.5mg Tirzepatide by subcutaneous injection. | 6 |
| Part A 5mg Tirzepatide Participants received single dose of 5mg Tirzepatide by subcutaneous injection. | 6 |
| Part A 8mg Tirzepatide Participants received single dose of 8mg Tirzepatide by subcutaneous injection. | 7 |
| Part B Placebo Participants received placebo by subcutaneous injection. | 4 |
| Part B 1.5mg Dulaglutide Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection. | 4 |
| Part B 0.5mg Tirzepatide Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection. | 6 |
| Part B 1.5mg Tirzepatide Participants received 1.5mg Tirzepatide once weekly for four weeks by subcutaneous injection. | 6 |
| Part B 4.5mg Tirzepatide Participants received 4.5mg Tirzepatide once weekly for four weeks by subcutaneous injections. | 6 |
| Part B 5, 5, 8,10mg Tirzepatide Participants 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. | 7 |
| Part C Placebo Participants received placebo by subcutaneous injection. | 11 |
| Part C 0.5mg Tirzepatide Participants received 0.5mg Tirzepatide once weekly for four weeks by subcutaneous injection. | 9 |
| Part C 5mg Tirzepatide Participants received 5mg Tirzepatide once weekly for four weeks by subcutaneous injection. | 9 |
| Part C 5, 5, 10,10mg Tirzepatide Participants 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. | 12 |
| Part C 5, 5, 10,15mg Tirzepatide Participants 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. | 12 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 2 |
| Overall Study | Scheduling Conflict | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A 0.25 mg Tirzepatide | Part A 0.5mg Tirzepatide | Part A 1mg Tirzepatide | Part A 2.5mg Tirzepatide | Part A 5mg Tirzepatide | Part A 8mg Tirzepatide | Part B Placebo | Part B 1.5mg Dulaglutide | Part B 0.5mg Tirzepatide | Part A Placebo | Part B 1.5mg Tirzepatide | Part B 4.5mg Tirzepatide | Part B 5, 5, 8,10mg Tirzepatide | Part C Placebo | Part C 0.5mg Tirzepatide | Part C 5mg Tirzepatide | Part C 5, 5, 10,10mg Tirzepatide | Part C 5, 5, 10,15mg Tirzepatide |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 133 Participants | 6 Participants | 12 Participants | 4 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 4 Participants | 6 Participants | 14 Participants | 6 Participants | 6 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants | 12 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 9 Participants | 8 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 6 Participants | 12 Participants | 5 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 4 Participants | 6 Participants | 14 Participants | 6 Participants | 6 Participants | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 94 Participants | 6 Participants | 12 Participants | 5 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 4 Participants | 6 Participants | 13 Participants | 6 Participants | 5 Participants | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 9 Participants | 7 Participants | 7 Participants | 11 Participants |
| Region of Enrollment Singapore | 96 Participants | 6 Participants | 12 Participants | 5 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 4 Participants | 6 Participants | 14 Participants | 6 Participants | 6 Participants | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 0 Participants |
| Region of Enrollment United States | 46 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 9 Participants | 8 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 34 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 0 Participants | 4 Participants | 6 Participants | 7 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 108 Participants | 5 Participants | 11 Participants | 4 Participants | 6 Participants | 6 Participants | 7 Participants | 4 Participants | 4 Participants | 6 Participants | 14 Participants | 6 Participants | 0 Participants | 7 Participants | 7 Participants | 3 Participants | 2 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 6 | 0 / 12 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 4 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 11 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 7 / 14 | 4 / 6 | 10 / 12 | 3 / 5 | 2 / 6 | 6 / 6 | 7 / 7 | 3 / 4 | 3 / 4 | 6 / 6 | 5 / 6 | 6 / 6 | 6 / 7 | 3 / 11 | 5 / 9 | 7 / 9 | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 | 0 / 12 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 4 | 1 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 11 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs)
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
Time frame: Baseline through Day 43 (Part A) and Day 57 (Part B and C)
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tirzepatide (Part A) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 0 Participants |
| Placebo (Part A) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 0 Participants |
| Tirzepatide (Part B) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 0 Participants |
| Placebo (Part B) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 0 Participants |
| Dulaglutide (Part B) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 1 Participants |
| Tirzepatide (Part C) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 0 Participants |
| Placebo (Part C) | Number of Participants With One or More Serious Adverse Event(s) (SAEs) | 0 Participants |
Secondary
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)
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).
Time frame: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23
Population: All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable day 23 PD data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Tirzepatide (Part A) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C) | 0.96 ratio |
| Placebo (Part A) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C) | 0.61 ratio |
| Tirzepatide (Part B) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C) | 0.58 ratio |
| Placebo (Part B) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C) | 0.57 ratio |
Secondary
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)
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).
Time frame: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2
Population: All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable day 2 PD data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Tirzepatide (Part A) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C) | 0.99 ratio |
| Placebo (Part A) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C) | 0.72 ratio |
| Tirzepatide (Part B) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C) | 0.65 ratio |
| Placebo (Part B) | Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C) | 0.73 ratio |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.
Area under the concentration versus time curve from zero to infinity (AUC \[0-∞\]) of Tirzepatide in Part A.
Time frame: Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43
Population: All randomized participants in part A who received at least one dose of Tirzepatide and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tirzepatide (Part A) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | 5760 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 22 |
| Placebo (Part A) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | 12000 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 24 |
| Tirzepatide (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | 22600 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 14 |
| Placebo (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | 53200 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 36 |
| Dulaglutide (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | 90500 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 15 |
| Tirzepatide (Part C) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A. | 169000 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 8 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B
Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part B. τ equals 168 hours.
Time frame: Predose, 8hours(h), 24h,48h,72h,168h postdose
Population: All randomized participants in part B who received at least one dose of the Tirzepatide and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tirzepatide (Part A) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B | 6000 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 23 |
| Placebo (Part A) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B | 16300 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 13 |
| Tirzepatide (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B | 53300 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 19 |
| Placebo (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B | 56900 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 10 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C
Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part C. τ equals 168 hours.
Time frame: Predose, 8hours(h), 24h,48h,72h,168h postdose
Population: All randomized participants in part C who received at least one dose of Tirzepatide and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tirzepatide (Part A) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C | 4770 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 30 |
| Placebo (Part A) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C | 50500 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 20 |
| Tirzepatide (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C | 41900 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 26 |
| Placebo (Part B) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C | 37990 Hour * nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 21 |