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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have been diagnosed with type 2 diabetes mellitus (T2DM).
  • Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
  • Have HbA1c between ≥7.0% and ≤9.5%.
  • Be of stable weight (± 5%) for at least 3 months before screening.
  • Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

  • Have type 1 diabetes mellitus.
  • Have had chronic or acute pancreatitis any time prior to study entry.
  • Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
  • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
  • Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².
  • Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
  • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
  • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Sites / Locations

  • National Research Institute
  • National Research Institute
  • Catalina Research Institute, LLC
  • Valley Clinical Trials, Inc.
  • National Research Institute
  • Southern California Dermatology
  • Clinical Research of South Florida
  • Encore Medical Research, LLC
  • Axcess Medical Research
  • South Florida Wellness & Clinical Research Institute
  • Suncoast Research Group, LLC
  • Agile Clinical Research Trials
  • Sky Clinical Research Network
  • Cotton O'Neil Clinic
  • Clinical Research Professionals
  • StudyMetrix Research, LLC
  • Aventiv Research
  • Intend Research
  • The Corvallis Clinic P.C.
  • Heritage Valley Medical Group, Inc.
  • Family Medical Associates
  • Preferred Primary Care Physicians
  • Preferred Primary Care Physicians
  • Dallas Diabetes Endocrine Center
  • Clinical Trials of Texas, Inc.
  • Consano Clinical Research
  • Capital Clinical Research Center
  • Rockwood Clinic Research Center
  • Dr. Jivraj Mehta Smarak Health Foundation
  • Bangalore Medical College and Research Institute
  • M S Ramaiah Medical College Hospital
  • BSES Municipal General Hsptl
  • Ruby Hall Clinic and Grant Medical Foundation
  • Vijay Vallabh Hospital
  • Lifepoint Multispecialty Hsptl
  • Ramdevrao Hospital
  • Gandhi Hospital
  • Minamiakatsuka Clinic
  • Takai Naika Clinic
  • Tsuruma Kaneshiro Diabetes Clinic
  • Yokohama Minoru Clinic
  • Takatsuki Red Cross Hospital
  • Meiwa Hospital
  • Tokyo-Eki Center-building Clinic
  • Tokyo Center Clinic
  • IHL Shinagawa East One Medical Clinic
  • Sato Naika Clinic
  • Hospital Universitario UANL
  • Unidad Medica para la Salud Integral (UMSI)
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasc
  • Investigacion en Salud y Metabolismo S.C
  • Clinical Research Puerto Rico, Inc.
  • GCM Medical Group PSC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Arm Description

Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.

Participants received 10mg of tirzepatide as subcutaneous injection once a week.

Participants received 15mg of tirzepatide as subcutaneous injection once a week.

Participants received placebo as subcutaneous injection once a week.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

Secondary Outcome Measures

Change From Baseline in Body Weight
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants With HbA1c Target Value of <7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Change From Baseline in Fasting Serum Glucose
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants With HbA1c Target Value of <5.7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Percentage of Participants Who Achieved Weight Loss ≥5%
Percentage of Participants who Achieved Weight Loss ≥5%.
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.

Full Information

First Posted
May 15, 2019
Last Updated
October 18, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03954834
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Acronym
SURPASS-1
Official Title
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
478 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
Participants received 10mg of tirzepatide as subcutaneous injection once a week.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
Participants received 15mg of tirzepatide as subcutaneous injection once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo as subcutaneous injection once a week.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (HbA1c)
Description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Weight
Description
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Percentage of Participants With HbA1c Target Value of <7%
Description
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time Frame
Week 40
Title
Change From Baseline in Fasting Serum Glucose
Description
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Percentage of Participants With HbA1c Target Value of <5.7%
Description
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time Frame
Week 40
Title
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
Description
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).
Time Frame
Baseline, Week 40
Title
Percentage of Participants Who Achieved Weight Loss ≥5%
Description
Percentage of Participants who Achieved Weight Loss ≥5%.
Time Frame
Week 40
Title
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia
Description
The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable.
Time Frame
Baseline through end of safety follow-up (up to week 44)
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Description
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.
Time Frame
Week 7, 15 and 23

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with type 2 diabetes mellitus (T2DM). Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening. Have HbA1c between ≥7.0% and ≤9.5%. Be of stable weight (± 5%) for at least 3 months before screening. Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening. Exclusion Criteria: Have type 1 diabetes mellitus. Have had chronic or acute pancreatitis any time prior to study entry. Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment. Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. Have an estimated glomerular filtration rate <30 mL/minute/1.73 m². Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Southern California Dermatology
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Encore Medical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
South Florida Wellness & Clinical Research Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Agile Clinical Research Trials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Sky Clinical Research Network
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Cotton O'Neil Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
StudyMetrix Research, LLC
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Intend Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
The Corvallis Clinic P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Family Medical Associates
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Dallas Diabetes Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Consano Clinical Research
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Capital Clinical Research Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Rockwood Clinic Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States
Facility Name
Dr. Jivraj Mehta Smarak Health Foundation
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Bangalore Medical College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 002
Country
India
Facility Name
M S Ramaiah Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
BSES Municipal General Hsptl
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400058
Country
India
Facility Name
Ruby Hall Clinic and Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Vijay Vallabh Hospital
City
Virar
State/Province
Maharashtra
ZIP/Postal Code
401303
Country
India
Facility Name
Lifepoint Multispecialty Hsptl
City
Wakad
State/Province
Pune
ZIP/Postal Code
411057
Country
India
Facility Name
Ramdevrao Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500072
Country
India
Facility Name
Gandhi Hospital
City
Telangana
ZIP/Postal Code
500003
Country
India
Facility Name
Minamiakatsuka Clinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4153
Country
Japan
Facility Name
Takai Naika Clinic
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Tsuruma Kaneshiro Diabetes Clinic
City
Yamato
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Facility Name
Yokohama Minoru Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Meiwa Hospital
City
Chiyodaku
State/Province
Tokyo
ZIP/Postal Code
101 0041
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
IHL Shinagawa East One Medical Clinic
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108 0075
Country
Japan
Facility Name
Sato Naika Clinic
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
Hospital Universitario UANL
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Unidad Medica para la Salud Integral (UMSI)
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasc
City
Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Facility Name
Investigacion en Salud y Metabolismo S.C
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Clinical Research Puerto Rico, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group PSC
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
35210595
Citation
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Results Reference
derived
PubMed Identifier
34186022
Citation
Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27. Erratum In: Lancet. 2021 Jul 17;398(10296):212.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/adult-type-2-diabetes/GPGK#?postal=
Description
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)

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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

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