The trial is taking place at:
F

ForCare Clinical Research | Tampa, FL

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

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Lilly

Status and phase

Active, not recruiting
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

700 estimated 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)

700 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

32

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Central trial contact

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

Data sourced from clinicaltrials.gov

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