AZD1043 safety and dosing in adults with overweight or obesity

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1043 Following Single and Multiple Ascending Doses Via Subcutaneous and/or Intravenous Administration in Healthy Adult Participants Living With Overweight and/or Obesity.

This will test the safety and how the body handles AZD1043 in adults living with overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 2 sites (Glendale, California and 1 other locations)
• Trial ID: NCT07511205 on ClinicalTrials.gov

What this trial studies

This is a phase 1, first-in-human, randomized, single-blind, placebo-controlled trial of AZD1043 in healthy adults living with overweight or obesity. The trial has single ascending dose (SAD) and multiple ascending dose (MAD) parts with separate global, Japanese, and Chinese cohorts to allow careful dose escalation. Female participants must be non-childbearing and all participants go through screening, an in-unit treatment period, and a safety follow-up. Primary measurements are safety, tolerability, pharmacokinetics, and pharmacodynamics after single and repeated dosing.

Who should consider this trial

Good fit: Healthy adults meeting the BMI and weight criteria (BMI 25–39.9 kg/m2 for global cohorts or 23–39.9 kg/m2 for Japanese/Chinese cohorts, and weight ≥50 kg) with women confirmed as non-childbearing are ideal candidates.

Not a fit: People who are pregnant, of childbearing potential without required contraception, have significant medical conditions, or who want immediate active weight-loss treatment are unlikely to benefit from this safety-focused phase 1 trial.

Why it matters

Potential benefit: If results are favorable, this could enable further development of AZD1043 as a potential new medication option for people with overweight or obesity.

How similar studies have performed: The SAD/MAD design is a standard early-stage approach that has supported development of other obesity drugs, but AZD1043 itself is first-in-human and currently unproven.

Eligibility criteria

Inclusion Criteria:

* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
* Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts \[Parts A1 and B1\]), or 23 and 39.9 kg/m2 (Japanese \[Parts A2 and B2\] and Chinese \[Part A3\] cohorts) inclusive and weigh at least 50 kg.
* For the Parts A2 and B2, participants should be Japanese (natives of Japan or Japanese Americans), having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
* For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.

Exclusion Criteria:

* History of any clinically important disease or disorder.
* 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 study intervention.
* Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043.
* Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit.
* History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable.

Where this trial is running

Glendale, California and 1 other locations

• Research Site — Glendale, California, United States (Recruiting)
• Research Site — Harrow, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Obesity; First time in human; Single ascending dose; Multiple ascending dose; Pharmacokinetics; Pharmacodynamics