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Completed

NCT Number: NCT04657003

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consultorio de Investigación Clínica EMO SRL, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
  • Have a BMI of ≥27 kg/m²
  • Are overweight or have obesity
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
  • Are at least 18 years of age and age of majority per local laws and regulations

Exclusion criteria

  • Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
  • Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
  • Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
  • Have self-reported change in body weight >5kg within 3 months prior to screening
  • Have had a history of chronic or acute pancreatitis
  • Change in body weight greater than 5 kg within 3 months prior to starting study
  • Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
  • Any lifetime history of a suicide attempt

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Other

Administered SC

Primary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 72

    Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline

    Time frame: Week 72

    Percentage of participants who achieve ≥5% body weight reduction from baseline

Secondary outcomes

  1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline

    Time frame: Week 72

    Percentage of participants who achieve ≥10% body weight reduction from baseline

  2. Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline

    Time frame: Week 72

    Percentage of participants who achieve ≥15% body weight reduction from baseline

  3. Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline

    Time frame: Week 72

    Percentage of participants who achieve ≥20% body weight reduction from baseline

  4. Change From Baseline in Absolute Body Weight

    Time frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  5. Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  6. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  7. Percentage of Participants Who Achieve HbA1c <7%

    Time frame: Week 72

    Percentage of participants who achieve HbA1c <7%

  8. Percentage of Participants Who Achieve HbA1c ≤6.5%

    Time frame: Week 72

    Percentage of participants who achieve HbA1c ≤6.5%

  9. Percentage of Participants Who Achieve HbA1c <5.7%

    Time frame: Week 72

    Percentage of participants who achieve HbA1c <5.7%

  10. Change From Baseline in Fasting Glucose

    Time frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

  11. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 72

    LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  12. Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.

  13. Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  14. Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  15. Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  16. Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  17. Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  18. Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  19. Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

    Time frame: Baseline, Week 72

    LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  20. Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)

    Time frame: Baseline, Week 72

    LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares).

  21. Percent Change From Baseline in Fasting Insulin

    Time frame: Baseline, Week 72

    Results are reported as model-based estimates and SE from MMRM analysis using log transformation.

  22. Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Time frame: Baseline, Week 72

    The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.

  23. Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score

    Time frame: Baseline, Week 72

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.

  24. Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide

    Time frame: Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose

    Each participant was assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose. The steady state AUC was evaluated using Population PK modeling.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)

Acronym: SURMOUNT-2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2020
Registry last updated
Apr 8, 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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