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Completed

NCT Number: NCT02759107

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

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.

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Key information

Conditions

Healthy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus (T2DM)

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Singapore

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Dulaglutide

Drug

Administered SC

Other names: Trulicity®

Primary outcomes

  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)

    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

  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

    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

    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

    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

    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

    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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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