Clinical trial NCT07017179: This is a Multi-centre, Multi-drug, Platform Study in Chinese Participants Living With Obesity/Overweight
Official title: A Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD6234, AZD9550, and AZD6234 in Combination With AZD9550 in Chinese Participants Living With Obesity/Overweight
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity/Overweight
Keywords: Obesity
Overweight
Chinese Participants
AZD6234
AZD9550
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety and tolerability, PK characterisation, efficacy, and immunogenicity of the study intervention, and it allows assessment of the monotherapy or combination therapy of AZD6234 and AZD9550 in different sub-studies.

Detailed description: This is a Phase Ⅱa, multi-centre, multi-drug, platform study in Chinese participants living with obesity/overweight. This platform study will consist of several sub-studies. Eligible participants will be allocated to one sub-study to receive the study intervention(s). Each sub-study will consist of a screening period, a treatment period, and a follow-up period.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 55 years.
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:

1. Have received prescription medication or non-prescription medication for weight loss within the last 3 months prior to screening.
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.

Primary outcomes:
measure: Numbers of participant with Adverse Events (AEs) and Serious adverse events (SAEs) (sub-study 1).
timeFrame: From baseline to Day 141
Secondary outcomes:
measure: PK parameters : Cmax (sub-study 1)
timeFrame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.
measure: PK parameters : Tmax (sub-study 1)
timeFrame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.
measure: PK parameters : AUClast (sub-study 1)
timeFrame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.
measure: PK parameters : AUCtau (sub-study 1)
timeFrame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85,106,113,120,127,141 Pre-dose. Day 1,36,43,57,106 post-dose 2,4,8,12,24,36,48,60,72,96 hours.
measure: Percent change in body weight from baseline to Week 16 (sub-study 1)
timeFrame: Day 1 to Day 141
measure: Incidence of ADA to AZD6234 (sub-study 1).
timeFrame: Day 1 to Day 141
measure: ADA titer of AZD6234 (sub-study 1).
timeFrame: Day 1 to Day 141
Other outcomes:
Locations:
city: Jinan
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
Study officials:
References: