A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

2022-502839-19-00 Protocol J2A-MC-GZGP Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 14 Sep 2023 · Status Ongoing, recruitment ended · 2 EU/EEA countries · 20 sites · Protocol J2A-MC-GZGP

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 3,000
Countries 2
Sites 20

Obesity

To demonstrate that orforglipron 6mg, 12mg and/or 36mg QD is superior to placebo for body weight

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
14 Sep 2023 → ongoing
Decision date (initial)
2023-09-04
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2022-502839-19-00
WHO UTN
U1111-1289-8877

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Dose response, Pharmacodynamic, Pharmacokinetic, Efficacy

To demonstrate that orforglipron 6mg, 12mg and/or 36mg QD is superior to placebo for body weight

Conditions and MedDRA coding

Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Have obesity or overweight
  2. If overweight, must also have one of the following:  High blood pressure, high cholesterol, obstructive sleep apnea or heart disease.
  3. Have at least 1 self-report of an unsuccessful at dietary effort to lose weight

Exclusion criteria 4

  1. Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  2. Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  3. Have family (first-degree relative) or personal history of MTC or MEN2 syndrome
  4. Have had a history of chronic or acute pancreatitis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Mean Percent Change from Baseline in Body Weight [Time Frame: Baseline to Week 72]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Orforglipron

PRD10193651 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193655 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193676 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193667 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193663 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193674 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Sodium Bicarbonate - Placebo to match LY3502970

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 11

OrganisationCity, countryDuties
Everest Clinical Research (Brightech International, LLC)
ORL-000001287
 Somerset, NJ, United States Code 10
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States E-data capture
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
IQVIA RDS (India) Private Limited
ORG-100047036
 Mumbai, India Laboratory analysis
Biotel Research LLC
ORG-100039864
 Rochester, United States Laboratory analysis
Techdata Service Company LLC
ORG-100047422
 Kng Of Prussa, United States Code 10
PPD Global Central Labs
ORG-100046496
 Zaventem, Belgium Laboratory analysis
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Iqvia Rds Inc.
ORG-100043858
 Durham, United States On site monitoring
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis

Locations

2 EU/EEA countries · 20 investigational sites

By country

CountryMS statusPlanned subjectsSites
Slovakia Ongoing, recruitment ended 239 7
Spain Ongoing, recruitment ended 277 13
Rest of world
Brazil, Argentina, India, Australia, Korea, Republic of, China, United States
 — 2,484 —

Investigational sites

Slovakia

7 sites · Ongoing, recruitment ended
Areteus s.r.o.
N/A, M. R. Stefanika 25a/3782, 075 01, Trebisov
DIA-MED CENTRUM s.r.o.
N/A, M. R. Stefanika 811, 020 01, Puchov
Medi-Dia s.r.o.
N/A, Namestie Slobody 65, 083 01, Sabinov
Vseobecna Nemocnica S Poliklinikou n.o.
N/A, Namestie Republiky 15, 984 01, Lucenec
DIAB s.r.o.
N/A, Namestie 1. Maja 11, 048 01, Roznava
MediTask s.r.o.
N/A, Vajnorska 1354/40, Nove Mesto, Bratislava
Metabol KLINIK s.r.o.
N/A, Cukrova 3, 811 08, Stare Mesto

Spain

13 sites · Ongoing, recruitment ended
Complexo Hospitalario Universitario A Coruna
Endocrinology, Lugar Jubias De Arriba 84, 15006, A Coruna
Centro Médico Teknon
Endocrinology, Carrer de Vilana, 12, Barcelona
Hospital Clinico Universitario De Valladolid
Endocrinology and nutrition, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitari Germans Trias I Pujol
Endocrinology and nutrition, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Torrecardenas
Endocrinology, Calle Paraje Torrecardenas S/n, 04009, Almería
Hospital Universitario Y Politecnico La Fe
Endocrinology and nutrition, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario De Valencia
Endocrinology and nutrition, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitari Vall D Hebron
Endocrinology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Area Sanitaria De Ferrol
Endocrinology, Avenida Residencia S/n, 15405, Ferrol
Hospital Virgen De Las Montanas
Internal Medicine, Paseo Ambulatorio Sn, 11650, Villamartin
Hospital Virgen Del Camino
Internal Medicine, Carretera De Chipiona Sn, 11540, Sanlucar De Barrameda
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Virgen De La Victoria
Endocrinology and nutrition, Calle Del Arroyo Teatinos S N, 29010, Malaga

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Slovakia 2023-09-18 2023-09-21 2024-02-05
Spain 2023-09-14 2023-09-18 2024-02-05

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Serious breach SB-23462

Sponsor became aware
2024-04-24
Date of breach
2024-03-04
Submission date
2024-05-01
Member states concerned
Spain, Slovakia
Categories
Protocol
Areas impacted
Subject safety
Benefit-risk balance changed
Yes
Description
Primary investigator (PI) failed to conduct the studies in compliance with protocols, agreements, and data integrity (ALCOA) principles. Multiple instances of GCP non-compliance with potential to impact patient safety and data integrity were identified during a directed site audit performed by the sponsor. Study procedures were recorded as conducted by the PI; the PI indicated they performed the activities remotely, but this was not documented or allowed per protocol. The PI admitted to backdating source records and dating and signing activities performed by the Sub-investigator but not delegated.
Sponsor actions
• Additional immediate actions are underway including the review of site's participation on other Lilly trials
• Stats will follow up with regulatory to discuss completing sensitivity analysis of data
• Study team released a letter on non-compliance to the PI and is discussing the decision to terminate the site and transfer participants to another site
OrganisationCityCountryType
Human-Care s.r.o. Kosice 1 Slovakia Clinical investigator

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2022-502839-19-00_Redacted d
Protocol (for publication) GZGP_Patient Documents Copyright 2.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_SK 1
Recruitment arrangements (for publication) K2_ Recruitment material_Letter Dr Referral 1.0
Recruitment arrangements (for publication) K2_Recruitment material_List of sites_SK_Redacted 2
Subject information and informed consent form (for publication) L1_Country_Specific_Main ICF_clean_Redacted 3.1
Subject information and informed consent form (for publication) L1_Country_Specific_Main ICF_Slovak_Highlighted_Redacted 2
Subject information and informed consent form (for publication) L1_Country_Specific_Main ICF_Slovak_Redacted 2.1
Subject information and informed consent form (for publication) L1_Country_Specific_Main ICF_Slovak_track changes_Redacted 2.1
Subject information and informed consent form (for publication) L1_ICF Addendum DXA Study_Redacted 1.0
Subject information and informed consent form (for publication) L1_ICF Data Privacy Addendum_SK 1.1
Subject information and informed consent form (for publication) L1_ICF Data Privacy Addendum_SK_track changes 1.1
Subject information and informed consent form (for publication) L1_ICF General_Redacted 3.0
Subject information and informed consent form (for publication) L1_ICF General_Track changes_Redacted 2.0
Subject information and informed consent form (for publication) L1_ICF Pregnant partner_SK 1.1
Subject information and informed consent form (for publication) L1_ICF Reimbursement_Redacted 1.0
Subject information and informed consent form (for publication) L1_Informed consent form SoC_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Informed consent form SoC_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Summary of changes 1_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Summary of changes 2_Redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material_Appreciation items_SK 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Information Card SK 4
Subject information and informed consent form (for publication) L2_Other subject information material_Study guide_Redacted 3
Subject information and informed consent form (for publication) L2_Patients cards 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis_SK_2022-502839-19-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_ES_2022-502839-19-00_Redacted d

Application history

9 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-05-12 Slovakia Acceptable
2023-09-04
 2023-09-04
2 SUBSTANTIAL MODIFICATION SM-1 2023-11-30 Slovakia Acceptable
2024-02-19
 2024-02-19
3 NON SUBSTANTIAL MODIFICATION NSM-1 2024-02-26 Slovakia Acceptable
2024-02-19
 2024-02-26
4 SUBSTANTIAL MODIFICATION SM-3 2024-03-13 Acceptable 2024-04-24
5 SUBSTANTIAL MODIFICATION SM-2 2024-03-15 Slovakia Acceptable 2024-05-07
6 SUBSTANTIAL MODIFICATION SM-4 2025-01-13 Slovakia Acceptable 2025-03-06
7 SUBSTANTIAL MODIFICATION SM-5 2025-06-13 Slovakia Acceptable
2025-07-30
 2025-07-31
8 SUBSTANTIAL MODIFICATION SM-6 2025-10-22 Slovakia Acceptable 2025-12-01
9 SUBSTANTIAL MODIFICATION SM-7 2025-10-29 Acceptable 2025-11-19

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