GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese

A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese

Lead sponsor

AstraZeneca

Asset

AZD6234

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-35•Healthy volunteers

Primary endpoint

•AEs and Serious Adverse Events(SAE)

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 IDNCT05511025

Org study IDD8750C00001

Timeline

Milestones

Study first posted2022-08-22actual

Study start2022-09-20actual

Primary completion2023-12-19actual

Study completion2023-12-19actual

Last update posted2023-12-26actual

Assets

Investigational agents

AZD6234

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Provision of signed and dated, written informed consent prior to any study specific procedures.

•Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.

•Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:

(i) Post menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle stimulating hormone (FSH) levels in the post menopausal range.

(ii) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

•Have a body mass index (BMI) of 25 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.

For the Japanese cohort(s):

•Participant is a native of Japan; defined as having both parents and four grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.

•Have a BMI of 23 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.

Exclusion criteria

•History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study, including:

(i) Gastroparesis (or similar) requiring treatment, or (ii) Previous surgery of the upper gastrointestinal tract, or (iii) Cardiovascular disease, including but not limited to sick sinus syndrome, valvular disease, and cardiomyopathy, or (iv) Neuromuscular or neurogenic disease, or (v) Severe vitamin D deficiency < 12 ng/dL (as assessed by screening laboratory results or history), or (vi) Type 1 or type 2 diabetes mellitus.

•History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.

•Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.

•Any laboratory values with the following deviations:

(i) Alanine aminotransferase > Upper limit of normal (ULN) (ii) Aspartate aminotransferase > ULN (iii) eGFR < 60 ml/min/1.73 m2 (calculated using the CKD EPI formula) (iv) White blood cell count < LLN (v) Hemoglobin < LLN (vi) Total calcium or corrected calcium/ionized calcium < LLN or > ULN

•Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

(i) Systolic Blood pressure (BP) < 90 mmHg or > 140 mmHg. (ii) Diastolic BP < 50 mmHg or > 90 mmHg. (iii) Heart rate < 55 or > 85 beats per minute (bpm)

•History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6234.

•Has received another new chemical entity (defined as a compound which has not been approved for marketing) within at least 30 days or 5 half-lives (whichever is longer) of the first administration of IMP in this study. The period of exclusion begins 30 days or 5 half-lives after the last visit in the previous study, whichever is the longest.

•Participants who are vegans or have medical dietary restrictions.

•Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

Endpoints (17)

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

Other (unclassified)

Safety / tolerability / PK

15 endpoints

Primary/protocol endpoint

Number of participants with AEs and Serious Adverse Events(SAE)

Time frame:From Screening until Follow up (Day 43)

event count, event

Secondary/protocol endpoint

Maximum observed plasma drug concentration (Cmax)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma concentration-time (AUClast)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Area under plasma concentration-time curve from zero to infinity (AUCinf)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Time to reach maximum observed concentration (tmax)

Time frame:From Day 1 until Follow up (Day 43)

time to event, event

Secondary/protocol endpoint

Terminal elimination half-life (t½λz)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Total body clearance of drug from plasma (IV dosing only) (CL)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Apparent total body clearance of drug from plasma (SC dosing only) (CL/F)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Volume of distribution based on the terminal phase (IV dosing only) (Vz)

Time frame:From Day 1 until Follow up (Day 43)

descriptive

Secondary/protocol endpoint

Apparent volume of distribution based on the terminal phase (SC dosing only) (Vz/F)

Time frame:From Day 1 until Follow up (Day 43)

descriptive

Secondary/protocol endpoint

Dose-normalized AUClast (AUClast/D)

Time frame:From Day 1 until Follow up (Day 43)

descriptive

Secondary/protocol endpoint

Dose-normalized AUCinf (AUCinf/D)

Time frame:From Day 1 until Follow up (Day 43)

descriptive

Secondary/protocol endpoint

Dose-normalized Cmax (Cmax/D)

Time frame:From Day 1 until Follow up (Day 43)

concentration, descriptive

Secondary/protocol endpoint

Prevalence and incidence of anti-drug antibodies (ADAs) to AZD6234

Time frame:Day 1, Day 15, Day 29 and at Follow up (Day 43)

event count, event

Secondary/protocol endpoint

ADA titer

Time frame:Day 1, Day 15, Day 29 and at Follow up (Day 43)

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Terminal rate constant (λz)

Time frame:From Day 1 until Follow up (Day 43)

descriptive

Secondary/protocol endpoint/low confidence

Time of last observed (quantifiable) concentration (tlast)

Time frame:From Day 1 until Follow up (Day 43)

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.