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

Short name SURMOUNT-5

NCTNCT05822830Other id17203Other idI8F-MC-GPHJOther idU1111-1283-5404

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 751 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 2 countries
United States, Puerto Rico
Start: 21 Apr 2023
Primary completion: 13 Nov 2024
Completion: 13 Nov 2024
First posted: 21 Apr 2023
Last update posted: 26 Nov 2025
Conditions: Obesity · Overweight

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 3
SURMOUNT-5
NCT05822830
21 Apr 2023 to 13 Nov 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TirzepatideDrug
SemaglutideDrug

Arms2

Experimental
15 mg or MTD - Tirzepatide
Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose \[MTD (10 mg or 15 mg)\] until Week 72.
Active comparator
2.4 mg or MTD - Semaglutide
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change From Baseline in Body Weight
Time frame · Baseline, Week 72
Registry description
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(8)

Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time frame · Week 72
Registry description
Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time frame · Week 72
Registry description
Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported.
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time frame · Week 72
Registry description
Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported.
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
Time frame · Week 72
Registry description
Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported.
Change From Baseline in Waist Circumference in Centimeter
Time frame · Baseline, Week 72
Registry description
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.
Percentage of Participants Who Achieve ≥30% Body Weight Reduction
Time frame · Week 72
Registry description
Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported.
Change From Baseline in Body Mass Index (BMI)
Time frame · Baseline, Week 72
Registry description
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.
Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide
Time frame · Baseline, Week 72
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 72