Clinical trial
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)
Name
17247
Description
This is a study of tirzepatide in participants with obesity or overweight. The main purpose is to learn more about how tirzepatide maintains body weight loss. The study has two phases: a lead-in phase in which all participants take tirzepatide and a treatment phase in which participants will either continue tirzepatide or switch to placebo. The study will last about 2 years (25 visits).
Trial arms
Trial start
2021-03-29
Estimated PCD
2023-04-25
Trial end
2023-05-18
Status
Completed
Phase
Early phase I
Treatment
Tirzepatide
Administered SC
Arms:
Tirzepatide
Other names:
LY3298176
Placebo
Administered SC
Arms:
Placebo
Size
783
Primary endpoint
Percent Change from Randomization (Week 36) in Body Weight
Randomization, Week 88
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 783, 'type': 'ACTUAL'}}
Updated at
2023-05-24
1 organization
1 product
1 indication
Organization
Eli Lilly and CompanyProduct
TirzepatideIndication
Obesity