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

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy
Type 2 Diabetes Mellitus (T2DM)

Treatments

Drug: Tirzepatide
Drug: Dulaglutide
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02759107
16119
I8F-MC-GPGA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 7 patient groups, including a placebo group

Tirzepatide (Part A)
Experimental group
Description:
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.
Treatment:
Drug: Tirzepatide
Placebo (Part A)
Placebo Comparator group
Description:
Participants received single dose of placebo by subcutaneous injection.
Treatment:
Drug: Placebo
Tirzepatide (Part B)
Experimental group
Description:
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.
Treatment:
Drug: Tirzepatide
Placebo (Part B)
Placebo Comparator group
Description:
Participants received placebo once weekly for four weeks by subcutaneous injection.
Treatment:
Drug: Placebo
Dulaglutide (Part B)
Active Comparator group
Description:
Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.
Treatment:
Drug: Dulaglutide
Tirzepatide (Part C)
Experimental group
Description:
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
Treatment:
Drug: Tirzepatide
Placebo (Part C)
Placebo Comparator group
Description:
Participants received placebo once weekly for four weeks by subcutaneous injection.
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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