Clinical Trials List
2023-06-16 - 2024-05-15
Phase III
Recruiting4
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)
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chun-Yuan Chu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hua-Shui Hsu Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
‧ Percent change in body weight
Inclution 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 OS)
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.
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.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
2100 participants
