Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
1,200
Countries
2
Sites
17
Obesity
To demonstrate that KAI-9531 subcutaneous (SC) once weekly (QW) is superior to semaglutide SC QW and placebo SC QW on percent change in body weight
Key facts
- Sponsor
- Kailera Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2026-05-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Kailera Therapeutics Inc.
External identifiers
- EU CT number
- 2025-523511-11-00
- ClinicalTrials.gov
- NCT07284979
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic, Pharmacodynamic, Others
To demonstrate that KAI-9531 subcutaneous (SC) once weekly (QW) is superior to semaglutide SC QW and placebo SC QW on percent change in body weight
Secondary objectives 6
- controlled for Type I error: To demonstrate that KAI-9531 SC QW is superior to semaglutide and placebo SC QW on change in body weight, and waist circumference
- controlled for Type I error: To demostrateKAI-9531 SC QW is superior to placebo SC QW on change in body weight, , SBP, lipid parameters, and IWQOL-Lite-CT
- not controlled for Type I error: To evaluate the effects of KAI9531 SC QW compared to semaglutide SC QW and placebo SC QW body weight, BMI, and patient reported outcome (CoEQ, IWQOL-Lite-CT, and FNQ)
- not controlled for Type I error: To evaluate the safety and tolerability of KAI-9531 SC QW compared to semaglutide SC QW and placebo SC QW
- not controlled for Type I error: To evaluate the immunogenicity of KAI-9531 SC QW
- not controlled for Type I error :To characterize the population PK of KAI-9531 SC QW and explore the relationships between the KAI-9531 concentration and efficacy, safety, and tolerability measures
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- BMI ≥35 kg/m
- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Exclusion criteria 10
- Current diagnosis or history of diabetes mellitus
- Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
- Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- Uncontrolled hypertension or unstable cardiovascular disease
- History of chronic or acute pancreatitis
- Known clinically significant gastric-emptying abnormality (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months prior to Screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent change in body weight (kg) from baseline at Week 76
Secondary endpoints 6
- controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5%,≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) Change in waist circumference (cm) Change in absolute body weight (kg)
- controlled for Type I error From baseline at Week 76 Percentage of participants with ≥5% reduction in body weight (kg) Change in - SBP − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change in WQOL-LiteCT Physical function composite score
- not controlled for Type I error from baseline at Week 76: • Percentage of participants with ≥30% reduction in body weight (kg) • Change in BMI (kg/m2) • Change in: − CoEQ Craving Control score − Positive Mood score − Craving for Sweets score − Craving for Savory food score − Hunger score − Satiety score − Combined score • Change in FNQ score
- not controlled for Type I error Number ofTEAEs
- not controlled for Type I error ADA NAb
- not controlled for Type I error Concentrations of KAI-9531
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD13091127 · Product
- Active substance
- TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL2-2- AMINOETHOXYETHOXYACETYL-2-2-AMINOETHOXYETHOXYACETYL-GAMMA-GLUTAMYL-EICOSANOYL-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL Amide
- Substance synonyms
- L-tyrosyl-2-methylalanyl-L-alfa-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-alfa-aspartyl-L-tyrosyl-L-seryl-L-isoleucyl-L-tyrosyl-N6-[N-(19-carboxy-1-oxononadecyl)-L-gamma-glutamyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-2-[2-(2-aminoethoxy)ethoxy]acetyl]-L-lysyl-L-alfa-glutamyl-L-lysyl-L-isoleucyl-L-alanyl-L-alanyl-L-glutaminyl-L-alfa-glutamyl-L-phenylalanyl-L-valyl-L-asparaginyl-L-tryptophyl-L-leucyl-L-leucyl-L-alanylglycylglycyl-L-prolyl-L-seryl-L-serylglycyl-L-alanyl-L-prolyl-L-prolyl-L-prolyl-L-serinamide, HRS 9531, KAI-9531, Ribupatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KAILERA
- Paediatric formulation
- No
- Orphan designation
- No
PRD13091128 · Product
- Active substance
- TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL2-2- AMINOETHOXYETHOXYACETYL-2-2-AMINOETHOXYETHOXYACETYL-GAMMA-GLUTAMYL-EICOSANOYL-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL Amide
- Substance synonyms
- L-tyrosyl-2-methylalanyl-L-alfa-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-alfa-aspartyl-L-tyrosyl-L-seryl-L-isoleucyl-L-tyrosyl-N6-[N-(19-carboxy-1-oxononadecyl)-L-gamma-glutamyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-2-[2-(2-aminoethoxy)ethoxy]acetyl]-L-lysyl-L-alfa-glutamyl-L-lysyl-L-isoleucyl-L-alanyl-L-alanyl-L-glutaminyl-L-alfa-glutamyl-L-phenylalanyl-L-valyl-L-asparaginyl-L-tryptophyl-L-leucyl-L-leucyl-L-alanylglycylglycyl-L-prolyl-L-seryl-L-serylglycyl-L-alanyl-L-prolyl-L-prolyl-L-prolyl-L-serinamide, HRS 9531, KAI-9531, Ribupatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KAILERA
- Paediatric formulation
- No
- Orphan designation
- No
PRD13091129 · Product
- Active substance
- TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL2-2- AMINOETHOXYETHOXYACETYL-2-2-AMINOETHOXYETHOXYACETYL-GAMMA-GLUTAMYL-EICOSANOYL-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL Amide
- Substance synonyms
- L-tyrosyl-2-methylalanyl-L-alfa-glutamylglycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-alfa-aspartyl-L-tyrosyl-L-seryl-L-isoleucyl-L-tyrosyl-N6-[N-(19-carboxy-1-oxononadecyl)-L-gamma-glutamyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-2-[2-(2-aminoethoxy)ethoxy]acetyl]-L-lysyl-L-alfa-glutamyl-L-lysyl-L-isoleucyl-L-alanyl-L-alanyl-L-glutaminyl-L-alfa-glutamyl-L-phenylalanyl-L-valyl-L-asparaginyl-L-tryptophyl-L-leucyl-L-leucyl-L-alanylglycylglycyl-L-prolyl-L-seryl-L-serylglycyl-L-alanyl-L-prolyl-L-prolyl-L-prolyl-L-serinamide, HRS 9531, KAI-9531, Ribupatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- KAILERA
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen
PRD9862209 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/006
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 1 mg FlexTouch solution for injection in pre-filled pen
PRD9862211 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/008
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen
PRD9862213 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/010
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen
PRD9862212 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/009
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen
PRD9862210 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/007
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kailera Therapeutics Inc.
3
Total trials
Commercial
- Sponsor organisation
- Kailera Therapeutics Inc.
- Address
- 890 Winter Street
- City
- Waltham
- Postcode
- 02451-1470
- Country
- United States
Scientific contact point
- Organisation
- Kailera Therapeutics Inc.
- Contact name
- Kailera Therapeutics, Inc
Public contact point
- Organisation
- Kailera Therapeutics Inc.
- Contact name
- Kailera Therapeutics, Inc
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Llx Solutions LLC ORG-100046614
|
Waltham, United States | Code 10 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other, Code 2, Code 5, Code 8 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Omnitrace Corp. ORG-100045579
|
Palm Beach Gardens, United States | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Frontage Laboratories Inc. ORG-100011515
|
Exton, United States | Laboratory analysis |
| Baim Institute For Clinical Research Inc. ORG-100047493
|
Boston, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
2 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 142 | 9 |
| Poland | Authorised, recruitment pending | 126 | 8 |
| Rest of world
Australia, United States, United Kingdom
|
— | 932 | — |
Investigational sites
Medical Center Hera EOOD
N/A, Ulitsa Tsar Boris Treti 11a, Fl 2, Montana
Endomedical Center OOD
N/A, 14-20 Sveti Georgi Sofiyski Str., 1431, Sofia
Diagnostic Consultative Center Equita OOD
N/A, Bulevard Tsar Osvoboditel 5, 9000, Varna
Endomedical Center OOD
N/A, 14-20 Sveti Georgi Sofiyski Str., 1431, Sofia
Medical Center-Sv. Dimitar EOOD
N/A, 8, Kumata Str., Sofia
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD
N/A, Ulitsa Boris Shivachev 14, 5801, Pleven
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Endocrinology and Metabolic Diseases, Zapaden District, Sofia Str 64, Plovdiv
Umbal - Prof. D-R Stoyan Kirkovich AD
Clinic of endocrinology and metabolic diseases, Ulitsa General Stoletov 2, 6003, Stara Zagora
Diamedical Medical Center 2013 Ltd.
N/A, Ulitsa Rodopski Izvor 104, 1680, Sofiya
Futuremeds Sp. z o.o.
FutureMeds Gdynia, Ul. Wladyslawa IV 59, 81-384, Gdynia
Centrum Medyczne Justmed Sp. z o.o.
ETG JustMed, Ul. Marymoncka 14/ U1 U2, 01-696, Warszawa
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Centrum Badań Klinicznych Przychodnia Badań Klinicznych, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Centrum Medyczne All-Med Badania Kliniczne
N/A, Ul. Henryka Sienkiewicza 23, 30-033, Cracow
Pratia S.A.
Centrum Medyczne Pratia Gdynia, Ul. Chrzanowskiego 3 Lok 5, 81-338, Gdynia
Diab Serwis Popenda Sp. j.
N/A, Jozefa Ryszki 51, 41-500, Chorzow
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
N/A, Ulica Zagórska 10/5, Świętokrzyskie, Kielce
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NZOZ Centrum Medyczne KERmed, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 40 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2025-523511-11-00 red | 1.2 |
| Protocol (for publication) | D1 Protocol Clarification Letter 2 2025-523511-11-00 red | N/A |
| Protocol (for publication) | D1 Protocol Clarification Letter 2025-523511-11-00 red | N/A |
| Protocol (for publication) | D4_Patient-facing document_COEQ-19_NRS_for publication placeholder | N/A |
| Protocol (for publication) | D4_Patient-facing document_FNQ_for publication placeholder | N/A |
| Protocol (for publication) | D4_Patient-facing document_IWQOL-Lite-CT_for publication placeholder | N/A |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_Part II_IN_Blank page for publication | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement form_PL_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN | 1.0 |
| Recruitment arrangements (for publication) | K2_1_Recruitment material_Participant Brochure_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_2_Recruitment material_Patient Flyer_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_3_Recruitment material_Participant Poster_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_4_Recruitment material_Physician Referral Letter_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_5_Recruitment material_Doctor-to-Participant Letter_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_6_Recruitment material_Pre-enrolment Information Card | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_7_Recruitment material_HCP Fact Sheet_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_8_Recruitment material_Study Information Slides_red-san | 01 BGR(bg) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor-to-Participant Letter_PL_red | V01POL02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Brochure_PL_red | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Poster_PL_red | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer_PL_red | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_PL_red | 01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pre-enrolment Information Card_PL_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L1_1_1_SIS and Main ICF_Master_red-san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and Main ICF_EN_red-san | 2.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and Main ICF_BG_red-san | V1.0BGR2.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and Pregnancy ICF_Master_red-san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and Pregnancy ICF_EN_red-san | 2.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and Pregnancy ICF_BG_red-san | V1.0BGR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_red | V1.0POL2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _Pregnant Partner ICF_PL_red | V1.0POL2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Wegovy FlexTouch 1 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Wegovy FlexTouch 2 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Wegovy FlexTouch 3 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Wegovy FlexTouch 4 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Wegovy FlexTouch 5 | N/A |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis BG 2025-523511-11-00 red | Original |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis EN 2025-523511-11-00 red | Original |
| Synopsis of the protocol (for publication) | D1 Protocol Synopsis PL 2025-523511-11-00 red | Original |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-21 | Poland | Acceptable 2026-04-27
|
2026-04-29 |