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Looking for Volunteers to Participate in a Clinical Study for Obesity

Obesity is a major risk factor for a number of chronic diseases, such as type 2 diabetes mellitus, and cardiovascular disease. AMG 133 is an investigational drug developed to treat obesity (a disorder involving excessive body fat that increases the risk of health problems). We are looking for volunteers to join a clinical study to evaluate the pharmacokinetics, safety, tolerability and production of antidrug antibodies of AMG 133 in overweight or obese Chinese subjects. The study will be conducted in the HKU Phase 1 Clinical Trials Centre (“Phase 1 Centre”), which is located in Queen Mary Hospital.

Study Information: 

  • This clinical study consists of 2 groups with different dose levels of the investigational drug. Each volunteer will only be invited to join either one group.
  • The entire study will take around 21 weeks, including screening, confinement and follow- up visits. Volunteers will be required to visit Phase 1 Centre to: 
    • perform screening procedures and baseline procedures; 
    • stay for 3 nights and receive investigational drug;
    • undergo follow-up assessments for approximately 13 times.
  • Study doctors will perform study-related procedures at no cost to qualified volunteers, including physical examinations, ECG assessment, blood pressure, pulse rate and body temperature measurements, and blood and urine tests etc. 
  • Cash allowance will be offered to volunteers to compensate for time spent, any inconvenience caused, and for covering transportation costs or other expenses which may incur.

Volunteers should meet the following criteria:

  • Aged between 18 and 65 years, inclusive
  • Chinese; Male or female without childbearing potential (Women surgically sterile or aged over 45 years being postmenopausal for ≥ 1 year)             
  • Body Mass Index (BMI)  between ≥ 24.0 and ≤ 40.0 kg/m2
    * BMI calculation: Weight (kg) ÷ Height (m) ÷ Height (m)
  • No history or current condition of serious chronic diseases (e.g. diabetes mellitus, endocrine or cardiovascular disease)
  • No HIV, hepatitis B or hepatitis C virus infection
  • No surgical procedures performed for treating obesity within past 6 months
  • Have had a stable body weight (<5 kg change) within past 3 months
  • No major nutritional lifestyle modification for 3 months

For enquiry, please contact our Volunteer Resource Centre: 
Telephone: 9681 2309 / 9685 7770 (please quote the study number CTC2446)
Web:  https://public.hkuctc.com/en 
Email: ctcvrc@hku.hk
IRB No.: UW 23-413

Study Timetable:

Group

Screening
(AM)

Baseline & Confinement

Follow-up Visit
(AM)

Group 1

3 Apr 2024 (Wed)
Or
5 Apr 2024 (Fri)
Or
8 Apr 2024 (Mon)
Or
9 Apr 2024 (Tue)
Or
10 Apr 2024 (Wed)
Or
11 Apr 2024 (Thu)

Baseline (AM):
24 Apr 2024 (Wed)

Confinement 
(4 Days 3 Nights) :

24 Apr 2024 (Wed)
to
27 Apr 2024 (Sat)


28 Apr 2024 (Sun)
to 2 May 2024 (Thu)

9 May 2024 (Thu)
16 May 2024 (Thu)
23 May 2024 (Thu)
6 Jun 2024 (Thu)
20 Jun 2024 (Thu)
4 Jul 2024 (Thu)
25 Jul 2024 (Thu)
22 Aug 2024 (Thu)

 

* Please confirm the final study dates with our staff