Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
360
Countries
1
Sites
6
Investigating obesity or overweight condition correlated to many co-morbidities
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss in percent change in body weight from baseline. To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5% in percent change in …
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
- 24 Feb 2025 → 12 May 2026
- Decision date (initial)
- 2025-02-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB Sweden
External identifiers
- EU CT number
- 2024-516176-15-00
- ClinicalTrials.gov
- NCT06862791
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy, Safety, Dose response, Efficacy, Pharmacokinetic
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss in percent change in body weight from baseline.
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5% in percent change in body weight from baseline.
Secondary objectives 6
- To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss in absolute change in body weight from baseline.
- To determine whether treatment with AZD9550 and AZD6234 in combination is superior to AZD9550 and AZD6234 monotherapy, and whether AZD9550 and AZD6234 as monotherapies are superior to placebo for weight loss in absolute change in body weight from baseline.
- To assess the effect of treatment with AZD9550 and AZD6234 in combination vs monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥5%
- To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo and monotherapy, and assess the effect of AZD9550 and AZD6234 as monotherapies vs placebo, on the proportion of participants with weight loss ≥10% and ≥15%
- To assess the immunogenicity profile of treatment with AZD9550 and AZD6234 in combination and as monotherapies
- To evaluate the safety and tolerability of AZD9550 and AZD6234 in combination compared with placebo and with monotherapy, and the safety and tolerability of AZD9550 and AZD6234 as monotherapies compared with placebo.
Conditions and MedDRA coding
Investigating obesity or overweight condition correlated to many co-morbidities
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, Medicines Evaluation Board, Federal Institute For Drugs And Medical Devices, Swedish Medical Products Agency
- 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 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 6
- Participant must be 18 to 75 years of age inclusive
- BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity
- A stable, self-reported body weight for 3 months prior to screening
- Male and female participants: Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
- Capable of giving signed informed consent
Exclusion criteria 12
- History of any clinically important disease or disorder, which, in the opinion of the Investigator
- History or presence of GI, renal, hepatic disease
- Previous or planned bariatric surgery or fitting of a weight loss device.
- Obesity induced by endocrine disorders such as Cushing’s syndrome, insulinoma or Prader-Willi syndrome.
- History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucose control.
- HbA1c≥ 6.5% (48 mmol/mol), fasting serum glucose≥126 mg/dL(7.0 mmol/L) or random glucose≥200 mg/dL (11.1 mmol/L).
- Significant gastric and hepatobiliary disease
- History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULN at screening.
- History of psychosis or bipolar disorder.
- History of major depressive disorder within the 2 years prior to screening or depression.
- Treatment with a GLP1 containing preparation, either as part of treatment or while participating in another clinical study within the3 months or 5 half-lives of the drug prior to screening
- Vulnerable populations
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percent change in body weight from baseline after 36 weeks of treatment
- Weight loss ≥ 5% from baseline after 36 weeks of treatment
Secondary endpoints 6
- Absolute change in body weight from baseline after 36 weeks of treatment
- Percent and absolute change in body weight from baseline after 36 weeks of treatment
- Weight loss ≥ 5% from baseline after 36 weeks of treatment
- Weight loss ≥ 10% and ≥ 15% from baseline after 36 weeks of treatment
- Prevalence, incidence and titres of ADAs to AZD9550 andAZD6234 in combination and as monotherapies after 36 weeks of treatment
- To evaluate the safety and tolerability of AZD9550 and AZD6234 in combination compared with placebo and with monotherapy
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10942337 · Product
- Active substance
- AZD9550
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 Other
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10248340 · Product
- Active substance
- AZD9550
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 Other
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10501952 · Product
- Active substance
- AZD6234
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 Other
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 3
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
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
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
Auxiliary 7
SCP116434309 · ATC
- Active substance
- Glucose
- Substance synonyms
- ANHYDROUS DEXTROSE, ANHYDROUS GLUCOSE, DEXTROSE (ANHYDROUS), DEXTROSE ANHYDROUS, DEXTROSE
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 9999 mg/Kg milligram(s)/kilogram
- Max total dose
- 9999 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- V04CA02 — GLUCOSE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2004265 · ATC
- Active substance
- Calcium
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 9999 g gram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- A12AA13 — CALCIUM CITRATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP135358 · ATC
- Active substance
- Cyclizine Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AE03 — CYCLIZINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP101859404 · ATC
- Active substance
- Calcium Gluconate
- Route of administration
- IV INFUSION
- Max daily dose
- 9999 g gram(s)
- Max total dose
- 9999 g gram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- A12AA03 — CALCIUM GLUCONATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1990227 · ATC
- Active substance
- Glucagon
- Route of administration
- NASAL USE
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- H04AA01 — GLUCAGON
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1155079 · ATC
- Active substance
- Ascorbic Acid
- Substance synonyms
- VITAMIN C, ASCORBIC ACID (E 300), CEVITAMIC ACID, (2R)-2-[(1S)-1,2-DIHYDROXYETHYL]-4,5-DIHYDROXY-FURAN-3-ONE
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 9999 g gram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- A12AA04 — CALCIUM CARBONATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP107195639 · ATC
- Active substance
- Ondansetron Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AA01 — ONDANSETRON
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- 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
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 6 |
| Rest of world
Canada, Australia, United States, Japan
|
— | 320 | — |
Investigational sites
diabetes-falkensee.de, ZKS Dr. Joerg Luedemann
NA, Poststrasse 46, 14612, Falkensee
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
NA, Markt 15, 23758, Oldenburg In Holstein
Velocity Clinical Research GmBH
NA, Ansbacher Strasse 17-19, Schoeneberg, Berlin
InnoDiab Forschung GmbH
NA, Eleonorastrasse 42, Ruettenscheid, Essen
Gemeinschaftspraxis für Innere Medizin und Diabetologie
Diabetes Zentrum Hamburg West, Beselerstrasse 2a, 22607, Hamburg
Institut fuer Diabetesforschung Muenster GmbH
NA, Hohenzollernring 70, Herz-Jesu, Muenster
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-02-24 | 2026-05-11 | 2025-02-24 | 2025-06-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516176-15_redacted | 5.0 |
| Protocol (for publication) | D4_Patient Facing Document_Symptom-Dosing Diary_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Germany | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Digital Advert | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Mannheim I | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Mannheim II | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genomic Research_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-04 | Germany | Acceptable 2025-02-03
|
2025-02-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-14 | Germany | Acceptable 2025-03-27
|
2025-04-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-29 | Germany | Acceptable 2025-08-14
|
2025-08-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-21 | Germany | Acceptable 2025-08-14
|
2025-11-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-04 | Germany | Acceptable | 2025-12-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-30 | Germany | Acceptable 2026-02-19
|
2026-02-19 |