Clinical trial • Phase III • Endocrinology
ORFORGLIPRON HEMICALCIUM for Obesity | Overweight | Type 2 diabetes
Phase III trial of ORFORGLIPRON HEMICALCIUM for Obesity | Overweight | Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity | Overweight | Type 2 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-04-2025
- First CTIS Authorization Date
- 23-07-2025
Trial design
Placebo to match LY (Placebo to match LY); no dose or schedule stated in CTIS record-controlled Phase III trial in Germany, Czechia.
- Comparator
- Placebo to match LY (Placebo to match LY); no dose or schedule stated in CTIS record
- Target Sample Size
- 1163
- Trial Duration For Participant
- 280
Eligibility
Recruits 1163 No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information and informed consent forms are provided (documents include L1_SIS and ICF_Main ICF_Redacted and country-specific ICFs such as CZ and DE). No assent or minor-consent procedures are described in the CTIS record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information and informed consent forms are provided (documents include L1_SIS and ICF_Main ICF_Redacted and country-specific ICFs such as CZ and DE). No assent or minor-consent procedures are described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- (GZP1) Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening: • hypertension • dyslipidemia • obstructive sleep apnea, or • cardiovascular disease\n- (GZP1) Have a history of at least one unsuccessful dietary effort to lose body weight\n- (GZP2) Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening\n- (GZP2) Have type 2 diabetes\n- (GZP2) Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening\n- (GZP2) Have a history of at least one unsuccessful dietary effort to lose body weight"}
Exclusion criteria
- {"criterion_text":"- (GZP1) Have type 1 diabetes, type 2 diabetes, or any other types of diabetes\n- (GZP2) Have type 1 diabetes\n- (GZP1, GZP2) Have an unstable body weight within 90 days prior to screening\n- (GZP1, GZP2) Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening\n- (GZP1, GZP2) Have acute or chronic hepatitis or pancreatitis\n- (GZP1, GZP2) Are taking other medications or alternative remedies to manage weight loss"}
Endpoints
Primary endpoints
- {"endpoint_text":"- (GZPO) Number of Participants Allocated to Each Study [Time Frame: Baseline to Week 4]\n- (GZP1) Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 40]\n- (GZP2) Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 40]","definition_or_measurement_approach":"(GZPO) Count of participants allocated to each study arm from baseline to Week 4. (GZP1) Percent change from baseline in body weight measured at baseline and Week 40. (GZP2) Change from baseline in HbA1c measured at baseline and Week 40. Time frames provided in endpoint text."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 1163
- Recruitment Window Months
- 22
- Consent Approach
- Informed consent materials are provided (Subject information and informed consent form documents: L1_SIS and ICF_main ICF_redacted, L1_SIS and ICF_Main ICF_Redacted, plus country-specific ICFs such as _CZ). Consent is provided by the adult participant; no assent or minor-consent procedures are described. Consent materials are available in multiple languages as indicated by document filenames (English, Czech, German).
Methods
- Patient recruitment materials: Flyers, Posters, Brochures (document titles: K2_Recruitment Material_GZP1 Flyer_Master, K2_Recruitment Material_GZP2 Flyer_Master, K2_Recruitment Material_GZP1 Poster_Master, K2_Recruitment Material_GZP2 Poster_Master, K2_Recruitment Material_GZP1 Brochure_Master, K2_Recrutiment Material_GZP2 Brochure_Master). Channel: printed and electronic patient-facing materials targeting adults with obesity or overweight (with/without type 2 diabetes).
- ClinLife Portal Patient Recruitment (document: K2_Recruitement material Clinlife Portal Patient Information) — digital recruitment channel targeting potential participants via the ClinLife portal.
- Letter-Doctor-Referral (document: K2_Recruitment materials_GZPT_Letter-Doctor-Referral_Master) — recruitment via healthcare professional referral.
- Patient-facing digital support: Atom5 eCOA Platform Participant Quick Reference Guide (document present) for participant electronic data capture and engagement.
- Site-based recruitment (implicit from multiple trial sites listed in Germany and Czechia) using local site outreach and referrals.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 237
Germany
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 276
- Number Of Sites
- 8
- Number Of Participants
- 157
Sites
- Site Name
- InnoDiab Forschung GmbH
- Contact Person Name
- Thomas Schuerholz
- Contact Person Email
- thomas.schuerholz@innodiab.de
- Site Name
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
- Department Name
- RED-Institut
- Contact Person Name
- Thomas Schaum
- Contact Person Email
- schaum@red-institut.de
- Site Name
- Diabetes-Zentrum-Wilhelmsburg GbR
- Department Name
- Diabetes Zentrum
- Contact Person Name
- Peter Witzel
- Contact Person Email
- p.witzel@diabetes-zentrum-wilhelmsburg.de
- Site Name
- Medizentrum Essen Borbeck
- Department Name
- Medizentrum
- Contact Person Name
- Axel Schaefer
- Contact Person Email
- axel.schaefer@mzeb.de
- Site Name
- Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
- Contact Person Name
- Heidrun Taeschner
- Contact Person Email
- dr.taeschner@web.de
- Site Name
- Medicover GmbH
- Department Name
- Neuroendokrinologie
- Contact Person Name
- Guenter Stalla
- Contact Person Email
- guenter.stalla@medicover.de
- Site Name
- Ambenet GmbH Das Ambulante Behandlungsnetz
- Contact Person Name
- Detlev Stahl
- Contact Person Email
- ds@ambenet.de
- Site Name
- Medizentrum Essen Borbeck (duplicate entry in CTIS list?)
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-07-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 281
- Number Of Sites
- 5
- Number Of Participants
- 80
Sites
- Site Name
- Donmed s.r.o.
- Department Name
- Interní, diabetologická a cévní ambulance
- Contact Person Name
- David Maděřič
- Contact Person Email
- david.maderic@centrum.cz
- Site Name
- Nemocnice Cesky Krumlov a.s.
- Department Name
- Interní oddělení
- Contact Person Name
- Richard Kovář
- Contact Person Email
- kovar@nemck.cz
- Site Name
- Medical Plus s.r.o.
- Contact Person Name
- Eva Dokoupilová
- Contact Person Email
- evadokoupil@gmail.com
- Site Name
- MUDr. Alena Váchová
- Department Name
- Diabetologie a obezitologie
- Contact Person Name
- Alena Váchová
- Contact Person Email
- alena.vachova@centrum.cz
- Site Name
- Milan Kvapil s.r.o.
- Department Name
- Diabetologická ambulance
- Contact Person Name
- Dagmar Bartášková
- Contact Person Email
- dagmar.bartaskova@centrum.cz
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 4, 5
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties code: 11
- Name
- Fisher Clinical Services, by Thermo Fisher Scientific
- Responsibilities
- Ancillary supplies (sponsorDuties code: 15)
- Name
- Clario
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"Switzerland","full_name":"Lionbridge AG","duties_or_roles":"Translation of R&R","organisation_type":"Health care"}
- {"country":"United States","full_name":"Fisher Clinical Services, by Thermo Fisher Scientific","duties_or_roles":"Ancillary supplies (sponsorDuties code: 15)","organisation_type":"Health care"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 4, 5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Study Development/Conduct – Study Training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 11","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Aparito Limited","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"IQVIA","duties_or_roles":"sponsorDuties codes: 1, 2, 3","organisation_type":"Health care"}
- {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"sponsorDuties code: 13","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Health care"}
- {"country":"United States","full_name":"OneStudyTeam","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Industry"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Orforglipron
- Active Substance
- ORFORGLIPRON HEMICALCIUM
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
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