Ph 1 Study to Evaluate Safety, Tolerability, PK & PD of Repeat AZD6234 Doses in Obese Participants
Research type
Research Study
Full title
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
IRAS ID
1009332
Contact name
Johan Holmgren
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
The trial is a multiple centre, randomized, single blind trial in up to 56 healthy males and females (of non-childbearing potential) between the ages of 18 and 55 years.
The medicine to be tested is this trial is a compound called AZD6234 being developed for treating obesity. Obesity is defined as having a BMI of 30 kg/m2 or greater. It is a risk factor for the development on many other conditions (eg, type 2 diabetes mellitus, heart disease, and chronic kidney disease).
The main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after repeated dosing by subcutaneous injection (an injection under the skin) to healthy male and female participants of non-childbearing potential who are overweight or have obesity. The clinical trial will also investigate the levels of the clinical trial medicine in your blood. The clinical trial will look at the immunogenicity (if your body has an immune reaction to the clinical trial medicine) and at the effect the clinical trial medicine has on your body weight and insulin levels (blood protein that regulates blood sugar). Lastly, the clinical trial will look at how the clinical trial medicine is taken up, metabolised (chemically broken down), distributed through the body, excreted, and how the body is affected by the clinical trial medicine.
The trial will comprise of:
- Screening period of a maximum 35 days
- Six In-house Treatment Periods (Once - 6 nights, three times - 2 nights, twice - 4 nights)
- 5 outpatient visits once a week
- 1 Follow up Visit
This is not a first-in-human trial.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0054
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Favourable Opinion