A study that follows the history of overweight male participants over a 30-year period would be

Brief Summary:

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.

Resource links provided by the National Library of Medicine

Primary Outcome Measures :

1. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]

   Percent Change from Baseline in Body Weight

   
   
2. Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 72 ]

   Percentage of Participants who Achieve ≥5% Body Weight Reduction

   
   

Secondary Outcome Measures :

1. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 20 ]

   Change from Baseline in Body Weight

   
   
2. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 176 ]

   Percent Change from Baseline in Body Weight

   
   
3. Percentage of Participants who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]

   Percentage of Participants who Achieve ≥10% Body Weight Reduction

   
   
4. Percentage of Participants who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]

   Percentage of Participants who Achieve ≥15% Body Weight Reduction

   
   
5. Percentage of Participants who Achieve ≥5% Body Weight Reduction [ Time Frame: Week 176 ]

   Percentage of Participants who Achieve ≥5% Body Weight Reduction

   
   
6. Percentage of Participants who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]

   Percentage of Participants who Achieve ≥20% Body Weight Reduction

   
   
7. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]

   Change from Baseline in Waist Circumference

   
   
8. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]

   Change from Baseline in BMI

   
   
9. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]

   Change from Baseline in Fasting Glucose

   
   
10. Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in Fasting Insulin

    
    
11. Time to Onset of Type 2 Diabetes [ Time Frame: Baseline through Week 176 ]

    Time to Onset of Type 2 Diabetes

    
    
12. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in HbA1c

    
    
13. Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in Triglycerides

    
    
14. Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in LDL Cholesterol

    
    
15. Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in Total Cholesterol

    
    
16. Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in HDL Cholesterol

    
    
17. Change from Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in VLDL Cholesterol

    
    
18. Change from Baseline in Free Fatty Acids [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in Free Fatty Acids

    
    
19. Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in Systolic Blood Pressure

    
    
20. Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in Diastolic Blood Pressure

    
    
21. Change from Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Baseline, Week 72 ]

    Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score

    
    
22. 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 ]

    Change from Baseline in IWQOL-Lite-CT Physical Function Composite Score

    
    
23. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 72 ]

    PK: Steady State AUC of Tirzepatide

    
    

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Inclusion Criteria:

• Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184622

Eli Lilly and Company

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Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.

Keywords provided by Eli Lilly and Company:

Additional relevant MeSH terms:

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Which type of study begins with a group of people who already have a disease and then looks into factors that are associated with that disease?

When neither the participants nor the experimenters know which group has received the treatment and which has received a placebo The design is called ______?

Which scientific method most strongly yields evidence for cause and effect relationships?

What is the placebo effect?