GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese

A Phase I Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 Following Repeat Dose Administration in Participants With Overweight or Obesity

Lead sponsor

AstraZeneca

Asset

AZD6234

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

104

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-40•Healthy volunteers

Primary endpoint

•Adverse Events (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 IDNCT06132841

Org study IDD8750C00002

Timeline

Milestones

Study start2023-11-13actual

Study first posted2023-11-15actual

Primary completion2026-02-03actual

Study completion2026-03-07actual

Last update posted2026-04-03actual

Assets

Investigational agents

AZD6234

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age142 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

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

•All 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:

1. Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.

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

•Have a BMI between 25 and 40 kg/m2 inclusive (at the time of screening) and weigh at least 60 kg.

•Participant must have an evaluable, pre-randomization MRI, as confirmed by the core laboratory review (Cohort 4 only).

•Cohort 4 only: Females of childbearing potential who use adequate protection (oral contraceptives are not permitted).

Exclusion criteria

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

•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 clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal STT wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.

•Known or suspected history of drug abuse, smoking, alcohol abuse or cotinine at screening.

•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 prescription or non-prescription medication for weight loss within the last 3 months.

•Self-reported weight change of > 5 kg in the last 3 months prior to screening.

•Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).

•Participants who follow vegan diet or have medical dietary restrictions.

•Participants who cannot communicate reliably with the Investigator.

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

•Contra-indication to MRI: such as participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with history of extreme claustrophobia or participant cannot fit inside the MRI scanner cavity (Cohort 4 only).

Endpoints (12)

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

Glycemic / diabetes

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change from baseline in body weight of participants

Time frame:From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Body Mass Index (BMI) of participants

Time frame:From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Percentage change from baseline in fasting insulin

Time frame:From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in absolute level of fasting insulin of participants

Time frame:From baseline (Day -1) to Day 43 (Cohort 1) or to Day 85 (Cohort 2 and 3) or to Day 183 (Cohort 4)

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

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

Time frame:From Screening (Day -35 to Day -3) to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

event count, event

Secondary/protocol endpoint

Maximum observed plasma drug concentration (Cmax)

Time frame:From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma concentration-time (AUClast)

Time frame:From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or Day 225 (Cohort 4)

concentration, descriptive

Secondary/protocol endpoint

Area under concentration time curve in the dosing interval (AUCtau)

Time frame:From Day 1 to Day 78 (Cohort 1) or to Day 120 (Cohort 2 and 3) or to Day 225 (Cohort 4)

concentration, descriptive

Secondary/protocol endpoint

Prevalence of anti-drug antibodies (ADAs) to AZD6234

Time frame:Day 1, 15, 36, and 78 (Cohort 1); Day 1, 15, 29, 43, 78 and 120 (Cohort 2 and 3) or to Day 183 (Cohort 4)

descriptive

Secondary/protocol endpoint

ADA titer

Time frame:Day 1, 15, 36, and 78 (Cohort 1); Day 1, 15, 29, 43, 78 and 120 (Cohort 2 and 3) or to Day 183 (Cohort 4)

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Incidence of ADAs to AZD6234

Time frame:Day 1, 15, 36, and 78 (Cohort 1); Day 1, 15, 29, 43, 78 and 120 (Cohort 2 and 3) to Day 183 (Cohort 4)

event count, event

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.