A Phase II Multicentre, Double Blind, Placebo Controlled, Parallel Group, Dose Ranging Study of ATL 962 to Assess Weight Loss, Safety and Tolerability in Obese Patients with Type II Diabetes being treated with Metformin, in comparison with orlistat - Dose-Ranging Study of ATL-962 in Obese Patients with Type II Diabetes
- Conditions
- Treatment of obesity in patients with Type II diabetes
- Registration Number
- EUCTR2004-000254-23-SE
- Lead Sponsor
- Alizyme Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1.The patient has provided written informed consent.
2.Male or female patients aged between 18 and 65 years of age (inclusive). Female patients must be either:
- post-menopausal (cessation of menses for at least one year)
- sterilised (hysterectomy, bilateral tubal ligation, bilateral oophorectomy)
- committed to sexual abstinence
- willing to use consistently and correctly one of the following contraceptive methods:
•Implants of levonorgestrel inserted for at least one month prior to the study drug administration, but not beyond the third successive year following insertion
•Injectable progestogen administered for at least one month prior to the study drug administration and administered for one month following study completion
•An intrauterine device, inserted at least one monthly cycle prior to study drug administration
•Vasectomised partner
•A combination of oral contraception with spermicidal covered condom. There are no data on the possible interactions between ATL-962 and oral contraceptives, therefore oral contraceptives must not be used as the sole form of contraception. Patients must not become pregnant for at least two weeks after cessation of study drug intake.
3.The patient has a body mass index (BMI) >28 kg/m² and <45 kg/m²
4.The patient has been diagnosed with Type II diabetes >3 months prior to the screening visit and treated on an outpatient basis.
5.The patient has a HbA1c >6% and <10% and has been maintained on the same dose of metformin for at least 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1.Female patients who are pregnant or lactating (A serum pregnancy test will be performed in females of child bearing potential at the screening visit and a urine pregnancy test at all subsequent visits)
2.Significant weight loss in the 3 months prior to screening
3.Weight gain during run-in period outside the pre-defined limit of 0.1Kg
4.History of any serious systemic disease with the exception of Type II diabetes, controlled hypertension (SBP <155 mmHg, DBP <90 mmHg), controlled mild asthma, controlled primary hypothyroidism (TSH = 1.5 times upper limit of normal at screening).
5.Requires medication that could interfere with the evaluation of the study drug (see section 3.3.6 of the protocol)
6.Clinically significant abnormalities on ECG
7.Evidence of impaired renal function (plasma creatinine >180 µmol/l) or impaired hepatic function, as shown by, but not limited to, AST or ALT =2 times the upper limit of normal at baseline
8.History of GI disorders, e.g. chronic inflammatory bowel disease, pancreatitis, pancreatic lipase deficiency, lactose intolerance or partial ileal bypass.
9.Evidence of GI disease that limits drug absorption.
10.Previous surgery for weight reduction.
11.Evidence of active malignant disease. Patients who have been disease free for at least 5 years may be included.
12.HIV or hepatitis C infection (Tests for HIV and hepatitis C will not be a study requirement).
13.History of anaphylaxis associated with medicinal products
14.Known or suspected hypersensitivity to ATL-962 or any of the excipients or other compounds related to this class of therapeutic agent.
15.Bulimia or evidence of laxative abuse.
16.Taken drugs capable of influencing weight loss in the last 6 months or orlistat at any time in the past
17.History of alcohol or substance abuse
18.Received treatment with other investigational agents or devices within the previous 3 months, has planned use of other investigational drugs or devices, or was previously enrolled in this trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method