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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05929066




Registration number
NCT05929066
Ethics application status
Date submitted
26/06/2023
Date registered
3/07/2023

Titles & IDs
Public title
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
Scientific 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)
Secondary ID [1] 0 0
J1I-MC-GZBJ
Secondary ID [2] 0 0
18557
Universal Trial Number (UTN)
Trial acronym
TRIUMPH-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Osteoarthritis, Knee 0 0
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Respiratory 0 0 0 0
Sleep apnoea
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Retatrutide
Treatment: Drugs - Placebo

Experimental: Retatrutide Dose 1 - Participants will receive retatrutide subcutaneously (SC).

Experimental: Retatrutide Dose 2 - Participants will receive retatrutide SC.

Experimental: Retatrutide Dose 3 - Participants will receive retatrutide SC.

Placebo comparator: Placebo - Participants will receive placebo.

Experimental: Retatrutide Extension Period - Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.


Treatment: Drugs: Retatrutide
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Body Weight
Timepoint [1] 0 0
Baseline, Week 80
Primary outcome [2] 0 0
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Timepoint [2] 0 0
Baseline, Week 80
Primary outcome [3] 0 0
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Timepoint [3] 0 0
Baseline, Week 80
Primary outcome [4] 0 0
Percent Change from Baseline in Body Weight to
Timepoint [4] 0 0
Baseline, Week 104
Secondary outcome [1] 0 0
Change from Baseline in Body Mass Index (BMI)
Timepoint [1] 0 0
Baseline, Week 80
Secondary outcome [2] 0 0
Change from Baseline in Waist Circumference
Timepoint [2] 0 0
Baseline, Week 80
Secondary outcome [3] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [3] 0 0
Baseline, Week 80
Secondary outcome [4] 0 0
Percent Change form Baseline in Fasting Insulin
Timepoint [4] 0 0
Baseline, Week 80
Secondary outcome [5] 0 0
Change from Baseline in HbA1c
Timepoint [5] 0 0
Baseline, Week 80
Secondary outcome [6] 0 0
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Timepoint [6] 0 0
Baseline, Week 80
Secondary outcome [7] 0 0
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Timepoint [7] 0 0
Baseline through Week 80
Secondary outcome [8] 0 0
Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset
Timepoint [8] 0 0
Baseline, Week 80
Secondary outcome [9] 0 0
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset
Timepoint [9] 0 0
Baseline, Week 80
Secondary outcome [10] 0 0
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset
Timepoint [10] 0 0
Baseline, Week 80
Secondary outcome [11] 0 0
Percent Change from Baseline in AHI for GSA1 Subset
Timepoint [11] 0 0
Baseline, Week 80
Secondary outcome [12] 0 0
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset
Timepoint [12] 0 0
Baseline to Week 80
Secondary outcome [13] 0 0
Percentage of Participants with =50% AHI Reduction from Baseline for GSA1 Subset
Timepoint [13] 0 0
Baseline to Week 80
Secondary outcome [14] 0 0
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10 for GSA1 Subset
Timepoint [14] 0 0
Week 80

Eligibility
Key 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

* 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

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
2300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,South AustVIC,WA
Recruitment hospital [1] 0 0
Emeritus Research - Botany
Recruitment hospital [2] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [3] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [4] 0 0
Fusion Clinical Research - Adelaide
Recruitment hospital [5] 0 0
Nightingale Research - Adelaide
Recruitment hospital [6] 0 0
Emeritus Research - Camberwell
Recruitment hospital [7] 0 0
Barwon Health - Geelong
Recruitment hospital [8] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
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Penzance
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285- 4559) or
Address 0 0
Country 0 0
Phone 0 0
317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05929066