A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Knee Pain Chronic; Obesity; Knee Osteoarthritis; Obstructive Sleep Apnea

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05929066

J1I-MC-GZBJ (Other Identifier)

2023-503657-35-00 (Other Identifier)

J1I-MC-GOA1 (Other Identifier)

18557

J1I-MC-GSA1 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,100 participants in 4 patient groups, including a placebo group

Retatrutide Dose 1

Experimental group

Description:

Participants will receive retatrutide subcutaneously (SC).

Treatment:

Drug: Retatrutide

Retatrutide Dose 2

Experimental group

Description:

Participants will receive retatrutide SC.

Treatment:

Drug: Retatrutide

Retatrutide Dose 3

Experimental group

Description:

Participants will receive retatrutide SC.

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo