TRIUMPH-1Retatrutide's Efficacy and Safety in Obesity or Overweight Management
This phase 3 study aims to evaluate the safety and effectiveness of Retatrutide in managing obesity or overweight, focusing on changes in body weight, Apnea-Hypopnea Index events, and pain levels as primary outcomes.
Retatrutide
+ Placebo
Apnea+20
+ Arthritis
+ Body Weight
Treatment Study
Summary
Study start date: July 10, 2023
Actual date on which the first participant was enrolled.This study focuses on evaluating the effectiveness and safety of a drug called retatrutide. It's designed for individuals who are overweight or have obesity, some of whom also have knee osteoarthritis or obstructive sleep apnea. The research aims to address these health conditions, potentially improving care and quality of life for those affected. The study is significant as it could provide valuable insights into managing these conditions, especially for those without type 2 diabetes. The trial spans approximately 89 weeks, with up to 24 visits. Participants receive retatrutide treatment once a week. The study measures changes in body weight, pain levels related to knee osteoarthritis, and the frequency of apnea-hypopnea events for those with sleep apnea. These measurements help determine the drug's efficacy. An optional addendum offers around 500 participants the chance to extend their treatment with retatrutide for up to an additional 24 weeks.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following: * hypertension * dyslipidemia * obstructive sleep apnea, or * cardiovascular disease * History of of at least one unsuccessful dietary effort to reduce body weight GOA1 Inclusion Criteria: * Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month * Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening * Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA. GSA1 Inclusion Criteria: * Previously diagnosed with OSA * Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA) * For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening. * If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits. GZBJ Addenda (2) inclusion criteria: * Have completed the final treatment visit of GZBJ Week 80. Exclusion Criteria: * Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days. * Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening. * Have a prior or planned surgical treatment for obesity. * Have diabetes mellitus. * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * Have had pancreatitis. GOA1 exclusion criteria * Have had steroid joint injections within 90 days of screening. * Have had other joint injections and procedures within 6 months of screening. * Have joint disease other than osteoarthritis. GSA1 exclusion criteria * Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening. * Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening. * Use a dental appliance or other device to treat OSA other than PAP therapy. GZBJ Addenda (2) exclusion criteria * Have had study intervention discontinuation. * Have had permanent dose reduction.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 134 locations
The AIM Centre / Hunter Diabetes Centre
Merewether, AustraliaOpen The AIM Centre / Hunter Diabetes Centre in Google MapsLogan Hospital
Meadowbrook, AustraliaCentral Phoenix Medical Clinic
Phoenix, United StatesArizona Research Center
Phoenix, United States