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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities (SURMOUNT-5)

Status and phase

Completed
Phase 3

Conditions

Overweight
Obesity

Treatments

Drug: Tirzepatide
Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05822830
U1111-1283-5404 (Other Identifier)
I8F-MC-GPHJ (Other Identifier)
17203

Details and patient eligibility

About

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.

Enrollment

751 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

751 participants in 2 patient groups

Tirzepatide
Experimental group
Description:
Participants will receive tirzepatide subcutaneously (SC).
Treatment:
Drug: Tirzepatide
Semaglutide
Active Comparator group
Description:
Participants will receive semaglutide SC.
Treatment:
Drug: Semaglutide

Trial contacts and locations

33

There are currently no registered sites for this trial.

Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Timeline

Last updated: Dec 11, 2024

Start date

Apr 21, 2023 • 2 years ago

End date

Nov 13, 2024 • 5 months ago

Today

May 10, 2025

Sponsor of this trial

Lead Sponsor

Data sourced from clinicaltrials.gov