Phase 3 · Semaglutide

SURMOUNT-5 trial results

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

Percent Change From Baseline in Body Weight (Percent change), Baseline, Week 72. 15 mg or MTD - Tirzepatide: -20.2; 2.4 mg or MTD - Semaglutide: -13.7.

Participants
751
Status
completed
Completed
2024-11-13
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05822830), updated at source Nov 26, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SURMOUNT-5 measured first

Percent Change From Baseline in Body WeightPercent change · Baseline, Week 72 · least squares mean
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
-20.2(0.59)-13.7(0.59)
Side effects by arm

Side effects in SURMOUNT-5

Percent of participants affected, Baseline Up To 72 Weeks. The most common events the registry lists.

Event15 mg or MTD - Tirzepatide2.4 mg or MTD - Semaglutide
Any serious event4.8%3.5%
Nausea43.6%44.4%
Constipation27%28.5%
Diarrhoea23.5%23.4%
Vomiting15%21.3%
Covid-1913.6%12.5%
Fatigue10.4%12.2%
Upper respiratory tract infection8.6%11.4%
Gastrooesophageal reflux disease6.1%10.6%
Eructation9.9%7.7%
Injection site reaction8.6%0.3%
Alopecia8.3%6.1%
Dyspepsia5.9%7.4%
Abdominal distension7.2%6.4%
Headache7.2%7.2%
Abdominal pain6.4%6.9%
Dizziness6.4%4.8%
Nasopharyngitis4.5%6.1%
Sinusitis2.9%5.6%
Decreased appetite4.5%5.1%
Secondary outcomes

What else it measured

Percentage of Participants Who Achieve ≥10% Body Weight ReductionPercentage of participants · Week 72 · number
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
87.766.7
Percentage of Participants Who Achieve ≥15% Body Weight ReductionPercentage of participants · Week 72 · number
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
71.745.0
Percentage of Participants Who Achieve ≥20% Body Weight ReductionPercentage of participants · Week 72 · number
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
55.031.1
Percentage of Participants Who Achieve ≥25% Body Weight ReductionPercentage of participants · Week 72 · number
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
36.518.6
Change From Baseline in Waist Circumference in Centimetercentimeters · Baseline, Week 72 · least squares mean
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
-18.4(0.61)-13.0(0.66)
Percentage of Participants Who Achieve ≥30% Body Weight ReductionPercentage of participants · Week 72 · number
15 mg or MTD - Tirzepatiden=3182.4 mg or MTD - Semaglutiden=318
23.08.2
Change From Baseline in Body Mass Index (BMI)kilograms per meter square · Baseline, Week 72 · least squares mean
15 mg or MTD - Tirzepatiden=3672.4 mg or MTD - Semaglutiden=373
-8.5(0.24)-6.0(0.24)
Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg SemaglutidePercent change · Baseline, Week 72 · least squares mean
15 mg or MTD - Tirzepatiden=3672.4 mg or MTD - Semaglutiden=373
-21.8(0.60)-15.4(0.60)
The trial

How SURMOUNT-5 was run

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.

  • 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.
  • 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.
Who could join the trial

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

Published papers

Papers from SURMOUNT-5

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.