ObesityPhase 2NCT03320941

A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

A Phase 2 study testing LIK066 in people with Obesity, run by Novartis Pharmaceuticals at 24 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Obesity
What is being tested?: LIK066
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 126 participants
Where: 24 sitesJapan
Study dates: 7 Dec 2017to 25 Jul 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Japan24 sites

Novartis Investigative Site
Ageo, Saitama, 362-8588
Novartis Investigative Site
Akashi, Hyōgo, 674-0081
Novartis Investigative Site
Chikushino-shi, Fukuoka, 818-0036
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0066
Novartis Investigative Site
Fukuoka, Fukuoka, 819-0006
Novartis Investigative Site
Hachiōji, Tokyo, 192-0046
Novartis Investigative Site
Higashiosaka, Osaka, 577-0802
Novartis Investigative Site
Higashiosaka, Osaka, 577-0803
Novartis Investigative Site
Kakogawa, Hyōgo, 675-0101
Novartis Investigative Site
Kawaguchi, Saitama, 332 0021
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-0857
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Kumamoto, Kumamoto, 860-0863
Novartis Investigative Site
Kumamoto, Kumamoto, 860-8039
Novartis Investigative Site
Kyoto, Kyoto, 600-8898
Novartis Investigative Site
Kyoto, Kyoto, 615-8125
Novartis Investigative Site
Matsudo, Chiba, 271 0077
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Nagasaki, Nagasaki, 850 0045
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Tokorozawa, Saitama, 359-0042
Novartis Investigative Site
Tokorozawa, Saitama
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Yokohama, Kanagawa, 231-0023

Other trials in Japan

About this study

Official title: 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

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.

Conditions: Obesity
Being tested: LIK066, Placebo
Keywords: Obesity disease, Over weight, T2DM, interventional study, Weight loss
Medical subject headings: Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIK066Drug
LIK066 will be supplied in different doses as tablets to be taken orally daily.
PlaceboDrug
Placebo will be supplied as tablets to be taken daily orally.

Study groups in NCT03320941
Study group	Role	What they receive
LIK066 2.5 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks. Receives: Drug: LIK066
LIK066 10 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks. Receives: Drug: LIK066
LIK066 25 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks. Receives: Drug: LIK066
LIK066 50 mg	Experimental	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks. Receives: Drug: LIK066
Placebo	Placebo comparator	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 12

Secondary outcomes (18)

Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for >=5% and >=10% was not calculated due to division by zero
Measured: Baseline, Week 12
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.
Measured: Baseline, Week 12
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
Waist circumference will be measured to the nearest 0.1 cm in a standing position, at the end of a normal expiration, using a tape at the level of umbilicus. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
HbA1c will be measured from a blood sample obtained and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake) at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, DBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
Fasting lipid profile (Triglycerides (TG)), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
Fasting lipid profile (total cholesterol), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
Fasting lipid profile (HDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
Fasting lipid profile (LDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
High sensitivity CRP will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Change From Baseline in Uric Acid at Week 12
Uric acid will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Change From Baseline on Urine Albumin at Week 12
Urine albumin will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
Urine albumin to creatinine ratio will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
VFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
SFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12
Measured: Baseline, Week 12
Pharmacokinetics - Plasma Trough Concentrations of LIK066
Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 201725 Jul 2018

First posted25 Oct 2017
Study start7 Dec 2017
Primary completion25 Jul 2018
Study completion25 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03320941
Sponsor's protocol ID: CLIK066B1201
Status last verified: Jun 2024
First submitted: 22 Oct 2017
Last updated: 26 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

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.
PubMed 32072763

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03320941
Acronym / sponsor ID: CLIK066B1201
Conditions: Obesity
Keywords: Obesity disease, Over weight, T2DM, interventional study, Weight loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 7 Dec 2017 (actual)
Primary completion: 25 Jul 2018 (actual)
Study completion: 25 Jul 2018 (actual)
First posted: 25 Oct 2017 (actual)
Results: Posted 2 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
LIK066 2.5 mg	Experimental	Drug: LIK066Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.
LIK066 10 mg	Experimental	Drug: LIK066Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.
LIK066 25 mg	Experimental	Drug: LIK066Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.
LIK066 50 mg	Experimental	Drug: LIK066Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboEligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LIK066LIK066 will be supplied in different doses as tablets to be taken orally daily.	Drug	LIK066 10 mg, LIK066 2.5 mg, LIK066 25 mg, LIK066 50 mg
PlaceboPlacebo will be supplied as tablets to be taken daily orally.	Drug	Placebo

Primary outcome

Percentage Change From Baseline in Body Weight at Week 12
Time frame: Baseline, 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.

18 secondary outcomes

Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
Time frame: Baseline, Week 12
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
Time frame: Baseline, Week 12
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
Time frame: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 12
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
Time frame: Baseline, Week 12
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 12
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
Time frame: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
Time frame: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
Time frame: Baseline, Week 12
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
Time frame: Baseline, Week 12
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
Time frame: Baseline, Week 12
Change From Baseline in Uric Acid at Week 12
Time frame: Baseline, Week 12
Change From Baseline on Urine Albumin at Week 12
Time frame: Baseline, Week 12
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
Time frame: Baseline, Week 12
Pharmacokinetics - Plasma Trough Concentrations of LIK066
Time frame: Week 12

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LIK066 2.5mg qd	19	19
LIK066 10mg qd	19	19
LIK066 25 mg qd	28	28
LIK066 50 mg qd	31	30
Placebo	29	29

Primary outcome: Percentage Change From Baseline in Body Weight at Week 12

Time frame: Baseline, Week 12. Number (95% Confidence Interval). Unit: Percent Change

Measure	LIK066 2.5mg qd n = 19	LIK066 10mg qd n = 19	LIK066 25 mg qd n = 28	LIK066 50 mg qd n = 31	Placebo n = 29
Value	-1.86 (-2.59 to -0.67)	-2.84 (-3.79 to -2.16)	-3.41 (-3.96 to -2.84)	-3.80 (-4.48 to -3.17)	0.11 (-0.90 to 0.97)

LIK066 2.5mg qd vs Placebo: Mean Difference (Net): -1.99 (95% CI -2.92 to -0.21)
LIK066 10mg qd vs Placebo: Mean Difference (Net): -3.00 (95% CI -4.15 to -1.70)
LIK066 25 mg qd vs Placebo: Mean Difference (Net): -3.54 (95% CI -4.54 to -2.26)

Population analysed: Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LIK066 2.5mg qd	0 of 19 (0%)	10 of 19 (52.6%)	0 of 19
LIK066 10mg qd	0 of 19 (0%)	12 of 19 (63.2%)	0 of 19
LIK066 25mg qd	0 of 28 (0%)	13 of 28 (46.4%)	0 of 28
LIK066 50mg qd	1 of 31 (3.2%)	20 of 31 (64.5%)	0 of 31
Placebo	0 of 29 (0%)	9 of 29 (31%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32072763Yokote 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.
A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Related trials for Obesity

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LIK066 in people with Obesity, run by Novartis Pharmaceuticals at 24 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Body Weight at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03320941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.