Clinical Trials Register

Summary
EudraCT Number:	2005-002454-21
Sponsor's Protocol Code Number:	014
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2005-07-12
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Ireland - HPRA

A.2

EudraCT number

2005-002454-21

A.3

Full title of the trial

A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of L-000899055 in Obese Patients

A.3.2

Name or abbreviated title of the trial where available

L-000899055: 1-Yr Weight Loss Followed by 1-Yr Prevention of Weight Regain

A.4.1

Sponsor's protocol code number

014

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp and Dohme Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Information not present in EudraCT
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	L-000899055
D.3.2	Product code	L-000899055
D.3.4	Pharmaceutical form	Capsule*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	L-000899055
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2, 4, 6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule*
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Obesity

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	7.1
E.1.2	Level	LLT
E.1.2	Classification code	10029883

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Phase A: In obese patients, to assess the effects of L-000899055 (L‘055 ) after 52 wks of treatment, on:1) body weight; 2) proportion of pts with metabolic syndrome (MS) 3) safety/ tolerability during treatment. Phase B: In obese pts who complete 52 wks of trt on L‘055 6 mg, to assess the effects in the 2nd year on:1) weight regain 2) safety/tolerability during trt.

E.2.2

Secondary objectives of the trial

Ph.A: In obese pts to assess the effects of L‘055 after 52 wks of trt on 1) waist circumference (WC) 2) biochemical markers 3) blood pressure (BP) 4) Patient-Reported Outcomes (PRO). Ph.B: In obese pts who complete 52 wks of trt on L-‘055 6 mg, to assess the effects of L‘055 in the 2nd year on:1) WC 2) biochemical markers 3) BP; 4) PRO. In obese pts. who experienced weight loss after completing 52 wks of trt on L‘055 6 mg, to assess the effects in the 2nd year on: 5) proportion who maintain ≥5% weight loss of their initial body weight 6) proportion who maintain ≥80% weight loss that occurred in the 1st year. In obese pts who complete 52 wks of trt on L‘055 4 or 6 mg, or pbo and continuing on the same trt, to assess the effects of L‘055 on 7) body weight after 104 wks of trt 8) proportion of pts with MS after 104 wks of trt.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

Body mass index (BMI) between 30 kg/m2 and 43 kg/m2
Patient meets at least 1 of the following 4 criteria:
• Triglyceride levels ≥ 150 mg/dL (1.69 mmol/L) but ≤ 600 mg/dL (6.8 mmol/L)
• HDL-C levels < 40 mg/dL (1.03 mmol/L) in men and < 50 mg/dL (1.29 mmol/L) in women
• Seated systolic blood pressure ≥ 130 mm Hg or seated diastolic blood pressure ≥ 85 mm Hg
• Impaired fasting glucose (FPG ≥ 100 mg/dL [5.5 mmol/L] and < 126 mg/dL [7.0 mmol/L])
Patient is ≥ 18 years of age.
Patient is highly unlikely to conceive
Patient is able to read and understands the study procedures and agrees to participate in the study by giving written informed consent.

E.4

Principal exclusion criteria

• Patients with a history or presence of a major DSM-IV-TR psychiatric disorder.
• Patients with recent (within 6 months prior to screening) diagnosis/episode/ recurrence of stroke or neurological.
• Patients with inadequately controlled hypertension.
• Patients with diabetes mellitus as defined by medical history, or a fasting blood glucose ≥126 mg/dL (7.0 mmol/L) or random blood glucose ≥200 mg/dL (11.1 mmol/L), or uses oral or injectable antihyperglycemic medications.
• Patients with any endocrinopathy, or patient has abnormal TSH at screening
• Patients with marked hypertriglyceridemia (fasting triglycerides >600 mg/dL [6.8 mmol/L]).
• Patients with significant cardiovascular disease, active liver disease or a history of chronic liver disease, significant pulmonary disease, significant gastrointestinal disease, significant renal disease or a history of neoplastic disease.
• Patients who are HIV positive as determined by medical history.
• Patients who are pregnant or lactating woman, or plan to become pregnant.
• Patients who have undergone surgical treatment for obesity.
• Patients with clinically significant abnormalities of laboratory safety tests including :Serum creatinine >1.5 times Upper Limit of Normal (ULN) (>2.1 mg/dL), Serum ALT and/or AST >2 times the ULN(ALT >50 mU/mL; AST >44 mU/mL) and hemoglobin <12.5 gm/dL [7.76 mmol/L] in men and <11.0 gm/dL [6.83 mmol/L] in women.
• Patients with viral hepatitis (hepatitis B or C).
• Patients who use or have used within 3 months prior to Visit 1 or plans to use any prescription or nonprescription drugs, including over- the-counter or herbal supplements.
• Patient treated with fenfluramine, dexfenfluramine either alone or in combination with any other medication at any time.
• Patients who use or are likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP 3A4 or who consume more than 1 quart (four 8 oz. glasses) of grapefruit juice per day at any time during the study..
• Patients with a history of substance abuse within the past 5 years.
• Patients who smoke cigarettes or used nicotine-containing products
• Patients who participated in a weight loss program involving pharmacologic treatment or dietary intervention during the 3 months prior to study start or intend to be involved in any such effort.
• Patients with clinically significant abnormalities of prestudy electrocardiogram, including but not limited to, prolonged QTc.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variables are body weight and percentage of patients with metabolic syndrome at Week 52. The primary efficacy variable of body weight consists of 3 endpoints: change from baseline at Week 52, proportion of patients who lose ≥5% of their baseline body weight (5% responders) and proportion of patients who lose ≥10% of their baseline body weight (10% responders) at Week 52.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Information not present in EudraCT
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-07-12.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	40
F.4.2	For a multinational trial
F.4.2.1	In the EEA	980
F.4.2.2	In the whole clinical trial	2400

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2005-09-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-09-08

P. End of Trial
P.	End of Trial Status	Completed

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