Multi-drug platform testing weight-loss medicines in Chinese adults with obesity or 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
This Phase 2 study will test whether the experimental medicines AZD6234 and AZD9550, alone or together, are safe and help Chinese adults aged 18–55 with obesity or overweight lose weight.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 871 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 3 sites (Jinan and 2 other locations) |
| Trial ID | NCT07017179 on ClinicalTrials.gov |
What this trial studies
This Phase 2a, multi-centre platform study in China will run several sub-studies that each include screening, a treatment period, and follow-up. Participants will be randomized within sub-studies to receive AZD6234, AZD9550, matching placebo, or a combination of AZD6234 and AZD9550, with roughly 18 participants in the AZD6234 monotherapy cohort and about 30 in the AZD9550 and combination cohorts. Treatment durations vary by sub-study (up to ~23 weeks for sub-study 1 and ~35 weeks for sub-study 2) and the study will collect safety, tolerability, pharmacokinetics, immunogenicity, and exploratory efficacy (including weight change) data. The protocol includes contraception requirements and a restriction on blood donation during participation and follow-up.
Who should consider this trial
Good fit: Adults aged 18–55 of Chinese ethnicity with BMI ≥ 27 kg/m2, stable weight for 3 months, not pregnant or breastfeeding, without diabetes and not using recent weight-loss medications are ideal candidates.
Not a fit: People with type 1 or type 2 diabetes, HbA1c ≥ 6.5%, recent use of prescription or non-prescription weight-loss drugs, gastroparesis requiring treatment, pregnant or breastfeeding individuals, or those outside the age/BMI ranges are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, these drugs could provide a new treatment option to help people with obesity or overweight lose weight and improve metabolic health.
How similar studies have performed: Other classes of weight-loss medications have demonstrated benefit, but AZD6234 and AZD9550 are investigational agents with limited published efficacy data in obesity.
Eligibility criteria
Show full inclusion / exclusion 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.
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.
Where this trial is running
Jinan and 2 other locations
- Research Site — Jinan, China (Active_not_recruiting)
- Research Site — Nanjing, China (Recruiting)
- Research Site — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.