Clinical trial • Phase III • Endocrinology
ORFORGLIPRON HEMICALCIUM for Obesity | Overweight
Phase III trial of ORFORGLIPRON HEMICALCIUM for Obesity | Overweight.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity | Overweight
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 30-10-2024
- First CTIS Authorization Date
- 12-03-2025
Trial design
Randomised, placebo to match ly3502970 (placebo comparator); no dose or schedule specified in the record-controlled Phase III trial across 8 sites in Italy, Poland.
- Randomised
- Yes
- Comparator
- Placebo to match LY3502970 (placebo comparator); no dose or schedule specified in the record
- Target Sample Size
- 114
- Trial Duration For Participant
- 504
Eligibility
Recruits 114 paediatric patients.
- Vulnerable Population
- The trial includes pediatric participants. Subject information and consent documents include assent forms for 12-17 year olds (e.g. 'Assent-12-17-yr') and parental/guardian consent forms (e.g. 'Main-ICF-Adult-Parent', 'Prescreening-ICF-Parent'). Documents are available in Italian and Polish (multiple ICFs and privacy addenda listed for IT and PL). Vulnerable population flag is selected in the record.
Inclusion criteria
- {"criterion_text":"- 1. Have been diagnosed with obesity or overweight with at least one weight-related comorbidity (abnormal lipids, high blood pressure, fatty liver disease, sleep apnea, prediabetes, or type 2 diabetes)"}
- {"criterion_text":"- 2. Have not been able to lose weight with healthy diet and physical activity"}
Exclusion criteria
- {"criterion_text":"- 1. Be prepubertal (have not started puberty)"}
- {"criterion_text":"- 2. Have lost more than 5 kg (11 pounds) in the 90 days before screening"}
- {"criterion_text":"- 3. Have type 1 diabetes"}
- {"criterion_text":"- 4. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2"}
- {"criterion_text":"- 5. Have had or plan to have a weight loss surgery during the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent Change from Baseline in Body Mass Index (BMI) [Time Frame: Baseline, Week 72]","definition_or_measurement_approach":"Percent change from baseline in BMI measured at Week 72 (time frame specified: Baseline, Week 72)."}
Recruitment
- Planned Sample Size
- 114
- Recruitment Window Months
- 21
- Consent Approach
- Parental/guardian informed consent required for minors; assent obtained from adolescents (documents listed: 'Assent-12-17-yr', 'Assent-12-17-yr_IT', 'Prescreening-assent-12-17-yr'). Multiple age-specific ICFs and prescreening ICFs exist (e.g. 'ICF-Main-13-17', 'ICF-Prescreening-under-13', 'ICF-Main-Adult-Parental'). Participant-facing documents and privacy addenda are provided in Italian and Polish (document list includes Italian and Polish ICFs and addenda).
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 11
Italy
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 12-03-2025
- Processing Time Days
- 112
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- UOC Trials-Sviluppo e implementazione farmaci,vaccini e dispositivi medici per uso pediatrico
- Principal Investigator Name
- MARCO CAPPA
- Principal Investigator Email
- marco.cappa@opbg.net
- Contact Person Name
- MARCO CAPPA
- Contact Person Email
- marco.cappa@opbg.net
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Pediatria
- Principal Investigator Name
- IVANA RABBONE
- Principal Investigator Email
- ivana.rabbone@uniupo.it
- Contact Person Name
- IVANA RABBONE
- Contact Person Email
- ivana.rabbone@uniupo.it
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Ospedale della Donna e del bambino, Ospedale Borgo Trento - UOC Pediatria B
- Principal Investigator Name
- CLAUDIO MAFFEIS
- Principal Investigator Email
- claudio.maffeis@univr.it
- Contact Person Name
- CLAUDIO MAFFEIS
- Contact Person Email
- claudio.maffeis@univr.it
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- SOC Diabetologia e Endocrinologia SS di Auxo-endocrinologia
- Principal Investigator Name
- STEFANO STAGI
- Principal Investigator Email
- stefano.stagi@unifi.it
- Contact Person Name
- STEFANO STAGI
- Contact Person Email
- stefano.stagi@unifi.it
Poland
- Earliest CTIS Part Ii Submission Date
- 14-02-2025
- Latest Decision Or Authorization Date
- 06-11-2025
- Processing Time Days
- 265
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Krakowskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Ewelina Malec
- Principal Investigator Email
- ewelina.malec@futuremeds.com
- Contact Person Name
- Ewelina Malec
- Contact Person Email
- ewelina.malec@futuremeds.com
- Site Name
- Futuremeds Sp. z o.o. (Wroclaw)
- Principal Investigator Name
- Paulina Ludziak
- Principal Investigator Email
- paulina.ludziak@futuremeds.com
- Contact Person Name
- Paulina Ludziak
- Contact Person Email
- paulina.ludziak@futuremeds.com
- Site Name
- Instytut Diabetologii Sp. z o.o.
- Principal Investigator Name
- Ewa Pańkowska
- Principal Investigator Email
- instytut@id.idsl.pl
- Contact Person Name
- Ewa Pańkowska
- Contact Person Email
- instytut@id.idsl.pl
- Site Name
- Futuremeds Sp. z o.o. (Warsaw)
- Principal Investigator Name
- Agata Zdanowska
- Principal Investigator Email
- agata.zdanowska@futuremeds.com
- Contact Person Name
- Agata Zdanowska
- Contact Person Email
- agata.zdanowska@futuremeds.com
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Codes: 1,11,12,2,4,5,6
- Name
- PPD Global Central Labs
- Responsibilities
- Code: 4
- Name
- Bioclinica Inc.
- Responsibilities
- ECG central reading & Imaging
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG central reading & Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Codes: 1,11,12,2,4,5,6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eCOA matertials development","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ORFORGLIPRON
- Active Substance
- ORFORGLIPRON HEMICALCIUM
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- prodAuthStatus:1
- Frequency
- Once daily
- Investigational Product Name
- Placebo to match LY3502970
- Modality
- Other
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