ClinicalTrials.Veeva

Menu
The trial is taking place at:
M

Medvadis Research | Waltham, MA

Veeva-enabled site

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

Lilly logo

Lilly

Status and phase

Enrolling
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

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

Trial contacts and locations

133

Loading...

Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285- 4559) or

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems