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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759107
• Other study ID #: 16119
• Secondary ID: I8F-MC-GPGA
• Status: Completed
• Phase: Phase 1
• Start date: May 11, 2016
• Est. completion date: June 26, 2017

Study information

• Verified date: April 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC
• Dulaglutide
Administered SC

Locations

Country	Name	City	State
Singapore	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
United States	Miami Research Associates	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Baseline through Day 43 (Part A) and Day 57 (Part B and C)
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 [0-8]) of Tirzepatide in Part A.	Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43
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-t]) of Tirzepatide in Part B. t equals 168 hours.	Predose, 8hours(h), 24h,48h,72h,168h postdose
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-t]) of Tirzepatide in Part C. t equals 168 hours.	Predose, 8hours(h), 24h,48h,72h,168h postdose
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).	Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2
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).	Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

External Links

•   Click here for more information about this study:A Study of tirzepatide in Participants With Type 2 Diabetes (T2DM)