TRIUMPH-1
Research type
Research Study
Full title
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants without Type 2 Diabetes who have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)
IRAS ID
1007006
Contact name
Veronica Acevedo
Contact email
Sponsor organisation
Eli Lilly and Co.
Research summary
Obesity is a chronic disease, and its increasing prevalence is a public health concern associated with rising incidence of type 2 diabetes, increased risk for premature death, and increased risk for some cancers.
Although weight loss has been shown to reduce complications related to obesity and improve quality of life, lifestyle therapies fail to achieve sustainable weight loss in the majority of patients who have obesity or overweight. Additionally, surgical advancements to treat obesity remain the only approved treatment that can achieve an average body weight reduction of 30 to 32%. However only about 1% of eligible patients are treated with surgical intervention.
Therefore, there is increasing recognition that complementary therapies are required in addition to lifestyle changes for patients who have obesity or overweight to achieve and maintain weight loss to improve health outcomes.
LY3437943 is a medicine that acts similar to GIP, GLP-1 and glucagon (natural hormones in the body). LY3437943 demonstrated body weight reduction in preclinical models, Phase 1 studies and Phase 2 studies. This Phase 3 study evaluates the efficacy and safety of LY3437943 in participants with obesity or overweight with at least 1 weight-related comorbid condition.
The purpose of this study J1I-MC-GZBJ (TRIUMPH-1) is to find out if the study medication LY3437943 can help patients who have obesity or overweight and who do not have type 2 diabetes mellitus (T2DM) when compared with placebo. An additional sub study J1I-MC-GOA1 will evaluate the efficacy and safety of LY3437943 in relieving knee pain due to osteoarthritis in participants who have obesity or overweight.
Participants will be randomly assigned to receive either LY3437943 or placebo.
Approximately 2100 participants globally will take part in the study including 119 in the UK. The study will last about 89 weeks.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0232
Date of REC Opinion
26 Oct 2023
REC opinion
Further Information Favourable Opinion