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Completed

NCT Number: NCT04657016

A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases 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

Centro Médico Viamonte, CABA, 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 a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
  • History of at least one unsuccessful dietary effort to lose body weight

Exclusion criteria

  • Diabetes mellitus
  • 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
  • History of pancreatitis
  • 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, 72 Weeks

    Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

  2. Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction

    Time frame: Week 72

    Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.

Secondary outcomes

  1. Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program

    Time frame: 72 Weeks

    Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  2. Percentage of Participants Who Achieve ≥10%Body Weight Reduction

    Time frame: 72 Weeks

    Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  3. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Time frame: 72 Weeks

    Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  4. Percentage of Participants Who Achieve ≥20% Body Weight Reduction

    Time frame: 72 Weeks

    Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

  5. Change From Baseline in Waist Circumference

    Time frame: Baseline, 72 Weeks

    Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  6. Change From Baseline in Body Weight

    Time frame: Baseline, 72 Weeks

    Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

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

    Time frame: Baseline, 72 Weeks

    Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment*Time (Type III sum of squares).

  8. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, 72 Weeks

    Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  9. Change From Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, 72 Weeks

    Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  10. Percent Change From Baseline in Total Cholesterol

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  11. Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  12. Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  13. Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  14. Percent Change From Baseline in Triglycerides

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  15. Percent Change From Baseline in Free Fatty Acids

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  16. Change From Baseline in Fasting Glucose

    Time frame: Baseline, 72 Weeks

    Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  17. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, 72 Weeks

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

  18. Percent Change From Baseline in Fasting Insulin

    Time frame: Baseline, 72 Weeks

    Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment*Time (Type III sum of squares).

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

    Time frame: Baseline, 72 Weeks

    The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 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" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.

    LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

  20. 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, 72 Weeks

    The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life.

    LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo After an Intensive Lifestyle Program in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double Blind, Placebo-Controlled Trial (SURMOUNT-3)

Acronym: SURMOUNT-3

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2020
Registry last updated
May 16, 2024

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

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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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