GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2

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

Lead sponsor

AstraZeneca

Assets

AZD6234 / AZD9550

Listed sites

Recruiting sites

Enrollment

871

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Numbers of participant with Adverse Events (AEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07017179

Org study IDD8750C00009

Timeline

Milestones

Study start2025-05-20actual

Study first posted2025-06-12actual

Last update posted2026-04-20actual

Primary completion2026-08-06estimated

Study completion2026-08-06estimated

Assets

Investigational agents

AZD6234 AZD9550

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Other (unclassified)

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Percent change in body weight from baseline to Week 16 (sub-study 1)

Time frame:From baseline to Week 16

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight from baseline to Week 28 (sub-study 2 ), placebo as comparator

Time frame:From baseline to Week 28

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight from baseline to Week 28 (sub-study 2, AZD9550 as comparator)

Time frame:From baseline to Week 28

percent change from baseline, improvement

Safety / tolerability / PK

16 endpoints

Primary/protocol endpoint

Numbers of participant with Adverse Events (AEs) and Serious adverse events (SAEs) (sub-study 1).

Time frame:From baseline to Day 141

descriptive

Primary/protocol endpoint

Numbers of participant with Adverse Events (AEs) and Serious adverse events (SAEs) (sub-study 2).

Time frame:From baseline to Day 225

descriptive

Secondary/protocol endpoint

PK parameters : Cmax (sub-study 1)

Time frame: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.

concentration, descriptive

Secondary/protocol endpoint

PK parameters : Tmax (sub-study 1)

Time frame: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.

concentration, descriptive

Secondary/protocol endpoint

PK parameters : AUClast (sub-study 1)

Time frame: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.

descriptive

Secondary/protocol endpoint

PK parameters : AUCtau (sub-study 1)

Time frame: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.

descriptive

Secondary/protocol endpoint

Incidence of ADA to AZD6234 (sub-study 1).

Time frame:Day 1 to Day 141

event count, event

Secondary/protocol endpoint

ADA titer of AZD6234 (sub-study 1).

Time frame:Day 1 to Day 141

descriptive

Secondary/protocol endpoint

PK parameters : Cmax (sub-study 2 Cohort A)

Time frame:Days 1, 15, 29, 57, 85, 113, 141, 190, 204, 211, 225 per dose. Days 1, 57, 113, 141,190 post-dose 6, 12, 18, 24 hours (± 10 minutes). Day 190 post-dos 30, 36, 42, 48, 54, 60, 72, 96, 120, 144,168 hours (± 30 minutes).

concentration, descriptive

Secondary/protocol endpoint

PK parameters : Tmax (sub-study 2 Cohort A)

concentration, descriptive

Secondary/protocol endpoint

PK parameters : AUClast (sub-study 2 Cohort A)

descriptive

Secondary/protocol endpoint

PK parameters : AUCtau (sub-study 2 Cohort A)

descriptive

Secondary/protocol endpoint

Incidence of ADA to AZD9550 (sub-study 2).

Time frame:Day 1 to Day 225

event count, event

Secondary/protocol endpoint

ADA titer of AZD9550 (sub-study 2 Cohort A).

Time frame:Day 1 to Day 225

descriptive

Secondary/protocol endpoint

Incidence of ADA to AZD6234 and AZD9550 combination therapy (sub-study 2 Cohort B).

Time frame:Day 1 to Day 225

event count, event

Secondary/protocol endpoint

ADA titer of AZD6234 and AZD9550 combination therapy (sub-study 2 Cohort B).

Time frame:Day 1 to Day 225

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Plasma trough concentration (sub-study 2 Cohort B).

Time frame:Day 1 to Day 225

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.