NCT03320941

Brief Summary

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 7, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

October 22, 2017

Results QC Date

July 23, 2019

Last Update Submit

June 25, 2024

Conditions

Obesity

Keywords

Obesity diseaseOver weightT2DMinterventional studyWeight loss

Outcome Measures

Primary Outcomes (1)

  • Percentage Change From Baseline in Body Weight at Week 12

    The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.

    Baseline, Week 12

Secondary Outcomes (18)

  • Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12

    Baseline, Week 12

  • Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)

    Baseline, Week 12

  • Change From Baseline at Week 12 on Waist Circumference at Umbilical Level

    Baseline, Week 12

  • Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)

    Baseline, Week 12

  • Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)

    Baseline, Week 12

  • +13 more secondary outcomes

Study Arms (5)

LIK066 2.5 mg

EXPERIMENTAL

Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.

Drug: LIK066

LIK066 10 mg

EXPERIMENTAL

Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.

Drug: LIK066

LIK066 25 mg

EXPERIMENTAL

Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.

Drug: LIK066

LIK066 50 mg

EXPERIMENTAL

Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.

Drug: LIK066

Placebo

PLACEBO COMPARATOR

Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.

Drug: Placebo

Interventions

LIK066DRUG

LIK066 will be supplied in different doses as tablets to be taken orally daily.

LIK066 10 mgLIK066 2.5 mgLIK066 25 mgLIK066 50 mg
PlaceboDRUG

Placebo will be supplied as tablets to be taken daily orally.

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
  • BMI ≥ 25 kg/m\^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m\^2 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 cm\^2
  • Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Novartis Investigative Site

Matsudo, Chiba, 271 0077, Japan

Location

Novartis Investigative Site

Chikushino-shi, Fukuoka, 818-0036, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 810-0066, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 819-0006, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-0857, Japan

Location

Novartis Investigative Site

Akashi, Hyōgo, 674-0081, Japan

Location

Novartis Investigative Site

Kakogawa, Hyōgo, 675-0101, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 231-0023, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 860-0863, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 860-8039, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 600-8898, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 615-8125, Japan

Location

Novartis Investigative Site

Nagasaki, Nagasaki, 850 0045, Japan

Location

Novartis Investigative Site

Higashiosaka, Osaka, 577-0802, Japan

Location

Novartis Investigative Site

Higashiosaka, Osaka, 577-0803, Japan

Location

Novartis Investigative Site

Ageo, Saitama, 362-8588, Japan

Location

Novartis Investigative Site

Kawaguchi, Saitama, 332 0021, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, 359-0042, Japan

Location

Novartis Investigative Site

Tokorozawa, Saitama, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0046, Japan

Location

Novartis Investigative Site

Kiyose, Tokyo, 204-0021, Japan

Location

Novartis Investigative Site

Minato-ku, Tokyo, 108-0075, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 141-0032, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0021, Japan

Location

Related Publications (1)

  • Yokote K, Sano M, Tsumiyama I, Keefe D. Dose-dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity. Diabetes Obes Metab. 2020 Jul;22(7):1102-1110. doi: 10.1111/dom.14006. Epub 2020 Mar 12.

    PMID: 32072763DERIVED

Related Links

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

licogliflozin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
novartis.email@novartis.com
8627788300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Parallel Assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2017

First Posted

October 25, 2017

Study Start

December 7, 2017

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

June 26, 2024

Results First Posted

October 2, 2019

Record last verified: 2024-06

Locations

JP(24)