This is a Multi-centre, Multi-drug, Platform Study in Chinese Participants Living With Obesity / Overweight
NCT ID: NCT07017179
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
871 participants
INTERVENTIONAL
2025-05-20
2026-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sub-study 1: AZD6234 Monotherapy This study will explore the safety, tolerability, pharmacokinetic (PK), efficacy, and immunogenicity of AZD6234 in Chinese participants with obesity/overweight, approximate 18 participants will be randomised in sub-study 1. The sub-study will comprise 3 periods totalling up to approximately 23 weeks.
Sub-study 2: AZD9550 Monotherapy and AZD6234 in combination with AZD9550 This study will explore the safety, tolerability, PK, efficacy, and immunogenicity of AZD9550 and of AZD6234 in combination with AZD9550 in Chinese participants with obesity/overweight, approximately 30 participants will be randomised in sub-study 2 (15 in Cohort A and 15 in Cohort B). The sub-study will comprise 3 periods totalling up to approximately 35 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD6234 (sub-study 1)
Participants will receive subcutaneous injection of AZD6234 on Day 1 and continue for 16 weeks.
AZD6234
Participants will receive a subcutaneous injection weekly
Placebo (sub-study 1)
Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 16 weeks.
Placebo
Participants will receive a subcutaneous injection weekly.
AZD9550（sub-study 2 Cohort A)
Participants will receive subcutaneous injection of AZD9550 on Day 1 and continue for 28 weeks.
AZD9550
Participants will receive a subcutaneous injection weekly
Placebo (sub-study 2 Cohort A)
Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks.
Plocebo
Participants will receive a subcutaneous injection weekly
AZD6234 in combination with AZD9550 (sub-study 2 Cohort B)
Participants will receive subcutaneous injection of AZD6234 and AZD9550 on Day 1 and continue for 28 weeks.
AZD6234 in combination with AZD9550
Participants will receive a subcutaneous injection weekly
Placebo (sub-study 2 Cohort B)
Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks.
Placebo
Participants will receive a subcutaneous injection weekly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD6234
Participants will receive a subcutaneous injection weekly
Placebo
Participants will receive a subcutaneous injection weekly.
AZD9550
Participants will receive a subcutaneous injection weekly
Plocebo
Participants will receive a subcutaneous injection weekly
AZD6234 in combination with AZD9550
Participants will receive a subcutaneous injection weekly
Placebo
Participants will receive a subcutaneous injection weekly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. BMI ≥ 27 kg/m2.
3. Stable body weight for 3 months prior to screening.
4. Male and female (Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies).
5. Participants should refrain from blodd donation throughout the sub-study, including the follow-up period.
6. Negative pregnancy test at screening and randomisation for FOCBP and must not be breastfeeding.
Exclusion Criteria
2. History of type 1 or type 2 diabetes mellitus or symptoms indicative of insulinopenia or poor glucose control.
3. Treatment with diabetes medication in past 3 months prior to screening.
4. HbA1c ≥ 6.5% (48 mmol/mol) at screening.
5. Gastroparesis (or similar) requiring treatment.
6. Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract.
7. Significant hepatic disease (except for non-alcoholic steatohepatitis or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
1. AST ≥ 2.5 × ULN
2. ALT ≥ 2.5 × ULN
3. TBL ≥ 1.5 × ULN.
8. Prior history of cholecystectomy or untreated cholelithiasis.
9. History of acute or chronic pancreatitis or pancreatic amylase or lipase \> 2 × ULN at screening.
10. Severely uncontrolled hypertension defined as systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg on the average of 2 seated measurements after being at rest for at least 5 minutes.
11. HR \< 50 bpm or \> 100 bpm after being at rest for 5 minutes.
12. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73 m2 at screening (GFR estimated according to CKD-EPI).
13. History of psychosis or bipolar disorder.
14. Severe vitamin D deficiency defined as a 25-OH vitamin D level \< 12 ng/mL.
15. Uncontrolled thyroid disease, defined as TSH \> ULN or \< LLN for the laboratory reference range, as judged by the PI at screening.
Sub-study 2 only
16. Personal or family history (first-degree relative) of MTC or MEN2.
17. History of marijuana or THC use within 3 months before screening, or unwilling/unable to abstain from marijuana or THC use during the study.
18. Previous hospitalisation for any psychiatric reason.
19. PHQ-9 score ≥ 15 within the 2 years prior to screening or at screening.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Jinan, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D8750C00009
Identifier Type: -
Identifier Source: org_study_id