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Clinical Trials/JPRN-jRCT2080223753
JPRN-jRCT2080223753
Completed
Phase 2

A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease

ovartis Pharma K.K.0 sites130 target enrollmentDecember 14, 2017
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ConditionsObesity

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obesity
Sponsor
ovartis Pharma K.K.
Enrollment
130
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 14, 2017
End Date
January 30, 2019
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ovartis Pharma K.K.

Eligibility Criteria

Inclusion Criteria

  • •\* Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
  • •\* BMI \>\= 25 kg/m2 combined with at least two obesity\-related comorbidities, or BMI \>\= 35 kg/m2 at least one obesity\-related comorbidity
  • •\* Patients with FPG \>\= 110 mg/dL and/or 5\.6% \<\= HbA1c \<\= 10\.0%, or T2DM with HbA1c \<\= 10\.0%
  • •\* Waist circumference at umbilical level \>\= 85 cm for male, \>\= 90 cm for female
  • •\* Visceral fat area \>\= 100 cm2
  • •\* Agreement to comply with the study\-required life\-style intervention and treatment during the full duration of the study

Exclusion Criteria

  • •\* Pregnancy or lactating women
  • •\* Use of pharmacologically active weight\-loss medications
  • •\* Bariatric surgery
  • •\* Ketoacidosis, lactic acidosis, hyperosmolar coma
  • •\* Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
  • •\* Gastro\-intestinal (GI) disorders associated with chronic diarrhea
  • •\* Congestive heart failure, New York Heart Association (NYHA) class III or IV

Outcomes

Primary Outcomes

Not specified

Similar Trials

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A study to evaluate the change in weight after 24 weeks treatment with LIK066 in obese or overweight adultschange in weight in obese or overweight adultsMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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