RecruitingPhase 2NCT07017179

This is a Multi-centre, Multi-drug, Platform Study in Chinese Participants Living With Obesity / Overweight

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

Sponsor

AstraZeneca

Enrollment

871 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

Age 18 to 55 years.
BMI ≥ 27 kg/m2.
Stable body weight for 3 months prior to screening.
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).
Participants should refrain from blodd donation throughout the sub-study, including the follow-up period.
Negative pregnancy test at screening and randomisation for FOCBP and must not be breastfeeding.

Exclusion Criteria23

Have received prescription medication or non-prescription medication for weight loss within the last 3 months prior to screening.
History of type 1 or type 2 diabetes mellitus or symptoms indicative of insulinopenia or poor glucose control.
Treatment with diabetes medication in past 3 months prior to screening.
HbA1c ≥ 6.5% (48 mmol/mol) at screening.
Gastroparesis (or similar) requiring treatment.
Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract.
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:
AST ≥ 2.5 × ULN
ALT ≥ 2.5 × ULN
TBL ≥ 1.5 × ULN.
Prior history of cholecystectomy or untreated cholelithiasis.
History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULN at screening.
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.
HR < 50 bpm or > 100 bpm after being at rest for 5 minutes.
Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73 m2 at screening (GFR estimated according to CKD-EPI).
History of psychosis or bipolar disorder.
Severe vitamin D deficiency defined as a 25-OH vitamin D level < 12 ng/mL.
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
Personal or family history (first-degree relative) of MTC or MEN2.
History of marijuana or THC use within 3 months before screening, or unwilling/unable to abstain from marijuana or THC use during the study.
Previous hospitalisation for any psychiatric reason.
PHQ-9 score ≥ 15 within the 2 years prior to screening or at screening.

Interested in this trial?

Get notified about updates and connect with the research team.