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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05872620




Registration number
NCT05872620
Ethics application status
Date submitted
15/05/2023
Date registered
24/05/2023

Titles & IDs
Public title
A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Scientific title
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)
Secondary ID [1] 0 0
J2A-MC-GZGQ
Secondary ID [2] 0 0
18560
Universal Trial Number (UTN)
Trial acronym
ATTAIN-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
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 - Orforglipron
Treatment: Drugs - Placebo

Experimental: Orforglipron Dose 1 - Participants will receive orforglipron administered orally.

Experimental: Orforglipron Dose 2 - Participants will receive orforglipron administered orally.

Experimental: Orforglipron Dose 3 - Participants will receive orforglipron administered orally.

Placebo comparator: Placebo - Participants will receive placebo


Treatment: Drugs: Orforglipron
Administered orally

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

Outcomes
Primary outcome [1] 0 0
Mean Percent Change from Baseline in Body Weight
Timepoint [1] 0 0
Baseline, Week 72
Secondary outcome [1] 0 0
Mean Change from Baseline in Waist Circumference
Timepoint [1] 0 0
Baseline, Week 72
Secondary outcome [2] 0 0
Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
Timepoint [2] 0 0
Baseline, Week 72
Secondary outcome [3] 0 0
Mean Change from Baseline in Fasting Glucose
Timepoint [3] 0 0
Baseline, Week 72
Secondary outcome [4] 0 0
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [4] 0 0
Baseline, Week 72
Secondary outcome [5] 0 0
Mean Change from Baseline in Fasting Triglycerides
Timepoint [5] 0 0
Baseline, Week 72
Secondary outcome [6] 0 0
Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol
Timepoint [6] 0 0
Baseline, Week 72
Secondary outcome [7] 0 0
Mean Percent Change from Baseline in Fasting Insulin
Timepoint [7] 0 0
Baseline, Week 72
Secondary outcome [8] 0 0
Mean Change from Baseline in Diastolic Blood Pressure (DBP)
Timepoint [8] 0 0
Baseline, Week 72
Secondary outcome [9] 0 0
Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores
Timepoint [9] 0 0
Baseline, Week 72

Eligibility
Key inclusion criteria
* Have a body mass index (BMI) =27.0 kilogram/square meter (kg/m²).
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
* Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c =7% (=53 mmol/mol) to =10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

* either diet/exercise alone or
* up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
* Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
* Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
* Have had a history of chronic or acute pancreatitis.

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
5/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,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
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Core Research Group - Brisbane
Recruitment hospital [5] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [6] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Emeritus Research - Camberwell
Recruitment hospital [9] 0 0
Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [10] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne - Melbourne
Recruitment hospital [11] 0 0
Advara HeartCare Joondalup - Joondalup
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4064 - Brisbane
Recruitment postcode(s) [5] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [6] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3124 - Camberwell
Recruitment postcode(s) [9] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Florida
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State/province [5] 0 0
Georgia
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Hawaii
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United States of America
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Idaho
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United States of America
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Iowa
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Maryland
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Michigan
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Missouri
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Nevada
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New Mexico
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New York
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North Carolina
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Oregon
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Tennessee
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Texas
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Virginia
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Argentina
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Ciudad Aut
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aire
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Santa Fe
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Argentina
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Tucumán
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Córdoba
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Distrito Federal
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Pardubice
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Plzen-mesto
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Czechia
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Praha 4
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Praha 8
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Czechia
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Praha-západ
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Czechia
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Stredoceský Kraj
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Hradec Kralove
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Plzen
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Ceský Krumlov
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Nordrhein-
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Gelnhausen
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Germany
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Hamburg
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Greece
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Attikí
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Greece
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Kentrikí Makedonía
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Greece
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Thessaloníki
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Greece
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Thessalía
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Greece
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Thessaloniki
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India
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Karnataka
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Madhya Pradesh
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Maharashtra
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India
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Tamil Nadu
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India
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Telangana
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Korea, Republic of
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Kang-won-do
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Kyongsangbuk-do
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Puerto Rico
State/province [80] 0 0
Bayamón
Country [81] 0 0
Puerto Rico
State/province [81] 0 0
Guaynabo

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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)?
Time Frame:

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/NCT05872620