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OpenTrials
Completed

NCT Number: NCT05822830

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Disease Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Puerto Rico Medical Research, Ponce, Puerto Rico

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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) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
  • Have a history of at least 1 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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

semaglutide

Drug

Administered SC

Primary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 72

    Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.

Secondary outcomes

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

    Time frame: Week 72

    Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.

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

    Time frame: Week 72

    Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported.

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

    Time frame: Week 72

    Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported.

  4. Percentage of Participants Who Achieve ≥25% Body Weight Reduction

    Time frame: Week 72

    Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported.

  5. Change From Baseline in Waist Circumference in Centimeter

    Time frame: Baseline, Week 72

    Change from baseline in waist circumference in centimeter was reported. LS mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.

  6. Percentage of Participants Who Achieve ≥30% Body Weight Reduction

    Time frame: Week 72

    Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported.

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

    Time frame: Baseline, Week 72

    Change from baseline in BMI was reported. LS mean was determined using Mixed Model Repeated Measures (MMRM) model using Baseline + Sex + Pre diabetes status at randomization + Treatment + Time + Treatment*Time(Type III sum of squares) as variables.

  8. Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide

    Time frame: Baseline, Week 72

    Percent change from baseline in body weight comparing 15mg of Tirzepatide and 2.4 mg Semaglutide was reported. The treatment effect for tirzepatide versus semaglutide for percent change in body weight was also evaluated assuming that participants had stayed on treatment and reached the highest dose of treatment. LS mean was determined by MMRM model using Baseline + Sex + Pre diabetes status at randomization + Baseline BMI Group 1 + Treatment + Time + Treatment*Time (Type III sum of squares) as variables.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities

Acronym: SURMOUNT-5

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Nov 26, 2025

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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