A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 Monotherapy and Co-administration of AZD9550 and AZD6234 in Participants Living with Obesity and Overweight with or without Type 2 Diabetes Mellitus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

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

28 Sep 2023 → ongoing

Decision date (initial)

2023-09-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB, Sweden

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacodynamic, Safety, Pharmacokinetic

Part A:
To evaluate the safety and tolerability of repeat SC doses of AZD9550 compared to placebo.
To characterize the PK of AZD9550 following repeat weekly SC doses.
Part B: To evaluate the safety and tolerability of multiple ascending SC doses of AZD9550 compared to placebo.
Part C: To evaluate the safety and tolerability of AZD9550 compared to placebo up to a maximum tolerated SC dose not higher than 00 mg over 24 weeks of dosing.
Part E - To evaluate the safety and tolerability of co administered AZD9550 and AZD6234 up to 00 mg and 00 mg, respectively, compared with placebo
Part F- To evaluate the safety and tolerability of AZD9550 administration, compared to placebo up to an SC MTD not higher than 00 mg over 28 weeks of dosing.

Secondary objectives 26

1. Part A - To characterize the PD effect of AZD9550 on glucose metabolism compared to placebo
2. Part A - To characterize the PD effect of AZD9550 on fasting lipid profile compared to placebo
3. Part A - To assess the effects of AZD9550 compared to placebo on glucose levels as measured by CGM across 4 weeks of treatment into the follow-up period
4. Part A - To assess the effects of AZD9550 compared to placebo on body weight and body fat (measured by bioimpedance)
5. Part A - To evaluate the immunogenicity profile of AZD9550
6. Part B - To assess the effect of AZD9550 on hepatic glycogen levels versus placebo after 5 weeks
7. Part B - To characterize the PD effect of AZD9550 on glucose metabolism compared to placebo
8. Part B - To characterize the PD effect of AZD9550 on fasting lipid profile compared to placebo
9. Part B - To assess the effect of AZD9550 on hepatic fat fraction versus placebo at Week 5
10. Part B - To assess the effects of AZD9550 compared to placebo on body weight and body fat (measured by bioimpedance)
11. Part B - To assess the effects of AZD9550 compared to placebo on glucose levels as measured by CGM across 5 weeks of treatment into the follow-up period
12. Part B - To characterize the PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo
13. Part B - To characterize the PK of AZD9550 following repeat weekly SC doses
14. Part B - To evaluate the immunogenicity profile of AZD9550
15. Part C - To characterise the PD effect of AZD9550 on glucose metabolism compared to placebo
16. Part C -To characterise the PD effect of AZD9550 on fasting lipid profile compared to placebo
17. Part C - To assess the effect of AZD9550 on hepatic fat fraction versus placebo after 13 and 24 weeks of treatment
18. Part C - To assess the effects of AZD9550 compared to placebo on body weight and body fat (measured by bioimpedance)
19. Part C - To assess the effects of AZD9550 compared to placebo on glucose levels as measured by CGM across 24 weeks of treatment into the follow-up period
20. Part C - To assess the effect of AZD9550 on fasting hepatic glycogen levels versus placebo after 13 and 24 weeks of treatment
21. Part C - To characterise the PK of AZD9550 following repeat weekly SC doses
22. Part C - To evaluate the immunogenicity profile of AZD9550
23. Part C- To characterise the PD effect of AZD9550 on glucose metabolism following an MMTT compared to placebo
24. Part E: To assess the immunogenicity profile of co administered AZD9550 and AZD6234 in combination
25. Part F: To assess the effects of AZD9550 compared to placebo on body weight
26. Part F: To evaluate the immunogenicity profile of AZD9550

Conditions and MedDRA coding

Overweight and obesity

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

Medical Products Agency, Federal Institute For Drugs And Medical Devices

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Males or females aged 18 through 65 years (Parts A-C) or 75 years (Part E-F) at the time of screening.
2. 2. Parts A, B, C only: Participants with or without T2DM. If participants have a diagnosis of T2DM, the glucose control is managed with diabetes diet and in addition to metformin treatment no more than two treatment options (with a stable dose 3 months prior to screening). Part E only: Participants are eligible to be included in the Part E only if they meet all of the following criteria at screening: a) Diagnosed with T2DM. b) Are treated with diet and exercise only, or any combination of OAD with stable doses in the 3 months prior to dosing. c) Participants prescribed a DPP IV inhibitor or a GLP-1RA-containing medicine, alone or in combination with other OADs, may be eligible to enter the study if they have not been treated with any of these drugs for at least 35 days or 5 drug half-lives (whichever is longer) prior to randomisation.
3. 3. Participants with a screening HbA1c value within the target range of: • ≥ 42 to ≤ 75 mmol/mol (6% to 9%). • Part F: < 48 mmol/mol (6.5%).
4. 4. Body mass index from ≥ 27 to ≤ 39.9 kg/m2 (inclusive) (Part A-C) or ≥ 27 kg/m2 (Part E), or ≥ 30 kg/m2 (Part F).
5. 5. Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. 6. Written informed consent and any locally required authorisation (eg, European Union Data Privacy Directive) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
7. 7. Ability to complete and meet all eligibility requirements for randomisation within 60 days after signing the ICF.
8. 8. Venous access suitable for multiple cannulations.
9. 9. Willing and able to "route of administration" weekly SC injections (Parts C, D, E, and F only).

Exclusion criteria 45

1. 1. Participants with T2DM (Part F) and participants with T2DM treated with insulin (Parts A-E).
2. 18. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
3. 19. Participants with implantable cardiac defibrillator or a permanent pacemaker, and participants with symptomatic tachy- or brady-arrhythmias.
4. 2. Participants with T2DM treated with more than 3 anti-diabetic therapies (Parts A-C only).
5. 20. Participants with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society class II or an acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention or coronary artery bypass grafting or stroke within 6 months.
6. 21. In Parts A-C: History of hospitalisation caused by heart failure or a diagnosis of heart failure. In Part E, severe congestive heart failure (New York Heart Association Class III or IV) or recent (< 6 months) hospitalisation due to heart failure.
7. 22. Known or suspected history of drug abuse within the past 3 years as judged by the investigator (Parts A-F) and/or a positive screen for drugs of abuse at screening (Parts A-C only).
8. 23. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
9. 24. Whole blood or red blood cell donation, or any blood loss > 500 mL (or > 400 mL in Part D) during the 3 months prior to screening.
10. 25. History of psychosis or bipolar disorder.
11. 30. History of lactic acidosis.
12. 10. Symptoms of insulinopenia or poor blood glucose control (eg, significant thirst, nocturia, polyuria, polydipsia, or weight loss).
13. 31. Use of any of the following medicinal products: - Use of systemic corticosteroids within 28 days prior to screening. - Use of compounds known to prolong the QTc interval. - Use of any herbal preparations or medicinal products licensed for control of body weight or appetite within 3 months prior to screening.
14. 32. Use of drugs with enzyme inducing properties such as St John’s Wort within 3 weeks prior to the first administration of study intervention.
15. 33. Received another new chemical entity (defined as a compound that has not been approved for marketing), or has participated in any other clinical study that included drug treatment within at least 30 days or 5 half-lives prior to the first administration of study intervention in this study (whichever is longer). The period of exclusion to begin 30 days or 5 half-lives of IMP after the final dose, or after the last visit, whichever is longest. Participants consented and screened, but not randomised into this study or previous AZD9550, AZD6234, or AZD9550/AZD6234 combination studies, are not excluded from Part E.
16. 3. Treatment with GLP-1RA or GLP-1RA/GIPRA within 3 months of screening (Parts A to C only) or within 35 days of randomisation or five half-lives (whichever is shorter) of dosing (Parts E and F only).
17. 34. Previous enrolment or randomisation in the present study.
18. 35. Concurrent participation in another study of any kind is prohibited.
19. 36. Ongoing weight loss diet (hypocaloric diet) or use of weight loss agents, unless the diet or treatment has been stopped at least 3 months prior to screening and the participant has had a stable body weight (± 5%) during the 3 months prior to screening.
20. 37. Participants who are vegans, ones with medical dietary restrictions, or participants who are willingly conducting any diet likely to increase ketone levels (Atkins or any similar diet based on increased protein consummation or low carbohydrate content) (Part A-C only).
21. 38. Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, Coca-Cola/Pepsi or similar drink type, chocolate) as judged by the investigator (Part A-C only)..
22. 39. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to screening (Part A-C only).
23. 11. Positive hepatitis B or hepatitis C virus serology at screening.
24. 40. Participants who cannot communicate reliably with the investigator or vulnerable participants (eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order).
25. 41. The participant is an employee, or close relative of an employee, of AstraZeneca, the Service Provider, or the study site, regardless of the employee’s role.
26. 42. Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
27. 43. Contra-indication to MRI: such as participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with history of extreme claustrophobia or participant cannot fit inside the MRI scanner cavity (Parts B and C only).
28. 4. History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study.
29. 5. Serum calcitonin suggestive of thyroid C-cell hyperplasia (calcitonin level > 50 ng/L), medullary thyroid carcinoma, or history or family history of multiple endocrine neoplasia at screening.
30. 6. History or presence of GI, renal, or hepatic disease (with the exception of Gilbert’s syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs, as judged by the investigator.
31. 7. History of cancer within the last 10 years, with the exception of non-melanoma skin cancer.
32. 8. Any clinically important illness (apart from T2DM), as judged by the investigator.
33. 9. Any medical/surgical procedure, or trauma within 4 weeks prior to screening, at the discretion of the investigator.
34. 12. Positive human immunodeficiency virus test at screening or participant taking antiretroviral medications as determined by medical history or participant’s verbal report.
35. 44. Serum triglyceride concentrations > 500 mg/dL (5.6 mmol/L) at screening or any other metabolic condition judged by the investigator as likely to precipitate acute pancreatitis (Part E only).
36. 45. History of use of marijuana or THC-containing products within 3 months prior to screening or unwillingness to abstain from marijuana or THC-containing products use during the study (Parts E and F only).
37. 13. At screening blood tests, any of the following:  AST ≥ 1.5 × ULN  ALT ≥ 1.5 × ULN  TBL ≥ 1.5 × ULN (with the exception of Gilbert’s syndrome)  Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator  Total serum calcium, albumin-corrected calcium or ionised calcium < LLN at screening (Part E).
38. 14. Impaired renal function defined as eGFR ≤ 60 mL/minute/1.73 m2 as defined by Chronic Kidney Disease Epidemiology Collaboration (2021) (Part A to C); or ≤ 45 mL/minute/1.73 m2 (Parts E and F).
39. 15. Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator.
40. 16. Significant late diabetic complications (macroangiopathy with symptoms of congestive heart disease or peripheral arterial disease, microangiopathy with symptoms of neuropathy, gastroparesis, retinopathy requiring treatment, nephropathy) detected in laboratory results or in clinical history/documentation as judged by the investigator.
41. 17. Abnormal vital signs, after 10 minutes of supine rest, defined as any of the following:  Systolic BP < 90 mmHg or ≥ 150 mmHg  Diastolic BP < 50 mmHg or ≥ 90 mmHg  HR < 50 or > 85 bpm at resting state  Participants may be re-tested for the vital signs criteria only once if, in the investigator’s judgement, they are not representative of the participant.
42. 26. History of major depressive disorder within the 2 years prior to screening or depression, where the participant is deemed to be clinically unstable as judged by the investigator.
43. 27. Previous hospitalisation for any psychiatric reason.
44. 28. Questionnaire score ≥ xx within the x years prior to screening or at screening (Parts E and F only).
45. 29. Active suicidal ideation defined as Category 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or Category 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS at any time prior to the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Parts A, B, C: • AEs and SAEs • Vital signs • ECG • Clinical laboratory assessments
2. Part A: • PK parameters (AUClast, AUCtau, Cmax, t1/2λz, tmax, CL/F, Vz/F, and other PK parameters if applicable) at first dose and last dose (at the same dose level) • Rac (AUCtau and Cmax)
3. Part E: • AEs, SAEs, and AESIs • Vital signs • ECG • Clinical laboratory assessments
4. Part F: • "CCI" • AEs and SAEs • Vital signs • ECG • Clinical laboratory assessments

Secondary endpoints 33

1. Part A • Absolute change from baseline to Week 4 in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c • Percent change from baseline to Week 4 in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c
2. Part A • Absolute and percentage change from baseline to Week 4 in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and ...
3. Part A • Absolute change from baseline to Week 4 in body weight • Percentage change from baseline to Week 4 in body weight • Absolute change from baseline to Week 4 in percentage body fat
4. Part A • Incidence and titre of ADA to AZD9550
5. Part B • Absolute change from baseline to Week 5 in fasting glucose, fasting insulin, fasting c-peptide and HbA1c • Percent change from baseline to Week 5 in fasting glucose, fasting insulin, fasting c-peptide and HbA1c
6. Part B • Absolute and percentage change from baseline to Week 5 in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglyceride, and ...
7. Part B • Change from baseline to Week 5 in hepatic fat fraction as measured by MRI-PDFF • Percent change from baseline to Week 5 in hepatic fat fraction as measured by MRI-PDFF
8. Part B • Absolute change from baseline to Week 5 in body weight • Percent change from baseline to Week 5 in body weight • Proportion of participants achieving ≥ 5% body weight loss from baseline to Week 5 • Proportion of participants achieving ≥ 10% body weight loss from baseline to Week 5 • Absolute change from baseline to Week 5 in percentage body fat
9. Part B • Percent change from baseline to Week 5 in glucose AUC(0-4h) measured by MMTT • Percent change from baseline to Week 5 in insulin AUC(0-4h) measured by MMTT • Percent change from baseline to Week 5 in c-peptide AUC(0-4h) measured by MMTT • Absolute change from baseline to Week 5 in fasting glucose, fasting insulin, and fasting c-peptide • Percent change from baseline to Week 5 in fasting glucose, fasting insulin, and fasting c-peptide
10. Part B • PK parameters (AUClast, AUCtau, Cmax, t1/2λz, tmax, CL/F, Vz/F, and other PK parameters if applicable) at the last dose
11. Part B • Incidence and titre of ADA to AZD9550
12. Part C • Absolute change from baseline to Week 24 in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c • Percent change from baseline to Week 24 in fasting glucose, fasting insulin, fasting c-peptide, and HbA1c
13. Part C • Absolute and percentage change from baseline to Week 24 in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and ...
14. Part C • Change from baseline to Weeks 13 and 24 in hepatic fat fraction as measured by MRI-PDFF • Percent change from baseline to Weeks 13 and 24 in hepatic fat fraction as measured by MRI-PDFF
15. Part C • Change from baseline to Week 24 in body weight • Percent change from baseline to Week 24 in body weight • Proportion of participants achieving ≥ 5% body weight loss from baseline to Week 24 • Proportion of participants achieving ≥ 10% body weight loss from baseline to Week 24 • Absolute change from baseline to Week 24 in percentage body fat
16. Part C • PK parameters (AUClast, AUCtau, Cmax, t1/2λz, tmax, CL/F, Vz/F, and other PK parameters if applicable) at the first doses of 00 mg, 00 mg, 00 mg and the last dose of MTD
17. Part C • Incidence and titre of ADA to AZD9550
18. Part B • Change in daily (24 hours) average glucose levels as measured by CGM from baseline to Weeks 1, 2, 3, 4, 5, and 6 • Change in 7-day average glucose levels as measured by CGM from baseline to Weeks 1, 2, 3, 4, 5, and 6 • Change in coefficient of variation of glucose levels as measured by CGM over 7 days from baseline to Weeks 1, 2, 3, 4, 5, and 6
19. Part B • Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 –140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours from baseline to Weeks 1, 2, 3, 4, 5, and 6• Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 –140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days from baseline to Weeks 1, 2, 3, 4, 5, and 6.
20. Part B • Change from baseline to Week 5 in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS • Percentage change from baseline to Week 5 in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS • Change from baseline to Week 5 in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
21. Part B • Percentage change from baseline to Week 5 in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS • Change in liver volume, visceral and subcutaneous fat as measured by MRI from baseline to Week 5
22. Part C • Change in daily (24 hours) average glucose levels as measured by CGM from baseline to each week of the treatment period, and during 14 days post last dose • Change in 7-day average glucose levels as measured by CGM from baseline to each week of the treatment period and during 14 days post last dose
23. Part C • Change in coefficient of variation of glucose levels as measured by CGM over 7 days from baseline to each week of the treatment period and during 14 days post last dose • Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 –140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours from baseline to each week of the treatment period and during 14 days post last dose
24. Part C • Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 –140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days from baseline to each week of the treatment period and during 14 post last dose
25. Part C • Change from baseline to Weeks 13 and 24 in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS • Percentage change from baseline to Weeks 13 and 24 in fasting hepatic glycogen concentration adjusted for liver volume as measured by MRS • Change from baseline to Weeks 13 and 24 in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS
26. Part C • Percentage change from baseline to Weeks 13 and 24 in fasting hepatic glycogen concentration unadjusted for liver volume as measured by MRS • Change in liver volume, visceral and SC fat as measured by MRI from baseline to Weeks 13 and 24
27. Part A • Change in daily (24 hours) average glucose levels as measured by CGM from baseline to Weeks 1, 2, 3, 4, 5, and 6 • Change in 7-day average glucose levels as measured by CGM from baseline to Weeks 1, 2, 3, 4, 5, and 6 • Change in coefficient of variation of glucose levels as measured by CGM over 7 days from baseline to Weeks 1, 2, 3, 4, 5, and 6
28. Part A • Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 –140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 24 hours from baseline to Weeks 1, 2, 3, 4, 5, and 6 • Change in percentage time spent in hyperglycaemia (> 140 mg/dL), normoglycaemia (70 –140 mg/dL), and clinically significant hypoglycaemia (< 54 mg/dL) as measured by CGM over 7 days from baseline to Weeks 1, 2, 3, 4, 5, and 6.
29. Part C • Percent change from baseline to Week 13 and Week 24 in glucose AUC(0-4h) measured by MMTT • Percent change from baseline to Week 13 and Week 24 in insulin AUC(0-4h) measured by MMTT • Percent change from baseline to Week 13 and Week 24 in c-peptide AUC(0-4h) measured by MMTT
30. Part C • Absolute change from baseline to Week 13 and Week 24 in fasting glucose, fasting insulin, and fasting c-peptide • Percent change from baseline to Week 13 and Week 24 in fasting glucose, fasting insulin, and fasting c-peptide
31. Part E: • Prevalence, incidence, and titres of ADAs to AZD9550 and AZD6234 in combination after 24 weeks of treatment
32. Part F: Change from baseline to Week 29 in body weight • Percent change from baseline to Week 29 in body weight • Proportion of participants achieving ≥ 5% body weight loss from baseline to Week 29 • Proportion of participants achieving ≥ 10% body weight loss from baseline to Week 29
33. Part F: • Incidence and titre of ADA to AZD9550

Investigational products

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

Test 3

Placebo 2

Auxiliary 10

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 1

Locations

3 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 43 files

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

Application history

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