The trial is taking place at:
R

Renstar Medical Research | Ocala, FL

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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Overweight
Obesity

Treatments

Drug: Tirzepatide
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04184622
17244
I8F-MC-GPHK (Other Identifier)

Details and patient eligibility

About

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Enrollment

2,539 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * History of at least one 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 * Any lifetime history of a suicide attempt

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2,539 participants in 4 patient groups, including a placebo group

5 mg Tirzepatide
Experimental group
Description:
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Treatment:
Drug: Tirzepatide
10 mg Tirzepatide
Experimental group
Description:
10 mg tirzepatide administered SC once a week.
Treatment:
Drug: Tirzepatide
15 mg Tirzepatide
Experimental group
Description:
15 mg tirzepatide administered SC once a week.
Treatment:
Drug: Tirzepatide
Placebo
Placebo Comparator group
Description:
Placebo administered SC once a week.
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

114

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Data sourced from clinicaltrials.gov

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