The trial is taking place at:
C

Chase Medical Research, LLC | Waterbury, MA

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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

115

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Data sourced from clinicaltrials.gov

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