Clinical trial NCT05132088: Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity
Official title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight and Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning.

In addition to taking the medicine, participants will have talks with study staff about:

* healthy food choices
* how to be more physically active
* what participants can do to lose weight The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional.

Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.


Eligibility criteria: Inclusion criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) of greater than or equal to 27.0 kg/m\^2 with greater than or equal to 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI greater than or equal to 35.0 kg/m\^2 with greater than or equal to1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2 diabetes (T2D)
* History of at least one self-reported unsuccessful dietary effort to lose body weight

For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-4:

* Diagnosed with T2D greater than or equal to 180 days prior to screening
* Treated with either diet and exercise alone or stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or thiazolidinediones)
* HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening

Exclusion criteria:

Participants without T2D only:

* HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes
* Treatment with glucose-lowering agent(s) within 90 days prior to screening
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR brlow 15 ml/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO) 2012 classification by the central laboratory at screening

Participants with T2D at screening only:

* Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening
* Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this study, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this study
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Renal impairment measured as eGFR value of below 30 mL/min/1.73 m\^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening
* In participants treated with SGLT2i, renal impairment measured as eGFR value of below 60 mL/min/1.73 m\^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening

The following criteria apply to all participants:

Obesity-related:

* Treatment with any medication indicated for weight management within 90 days prior to screening
* Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening, (2) lap banding, if the band has been removed greater than 1 year prior to screening, (3) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year prior to screening
* Uncontrolled thyroid disease per investigators discretion
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of body weight reduction greater than or equal to 5% (Yes/No)
timeFrame: At end of treatment (week 68)
Secondary outcomes:
measure: Achievement of body weight reduction greater than or equal to 10% (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Change in Physical function domain (5-items) score (IWQOL-Lite-CT)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Achievement of body weight reduction greater than or equal to 15% (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Achievement of body weight reduction greater than or equal to 20% (Yes/No)
timeFrame: At end of treatment (week 68)
measure: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in waist circumference measured according to the JASSO guideline
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population
timeFrame: From baseline to end of treatment (week 68)
measure: Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population
timeFrame: From baseline to end of treatment (week 68)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in diastolic blood pressure
timeFrame: From randomisation (week 0) to end of treatment (week 68)
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: Total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: high density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: very-low density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in lipids: Free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in high sensitivity C Reactive Protein
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of treatment emergent adverse events
timeFrame: From baseline (week 0) to end of study (week 75)
measure: Number of serious adverse events
timeFrame: From baseline (week 0) to end of study (week 75)
Other outcomes:
Locations:
city: Sapporo city
country: Japan
facility: Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital
state: Hokkaido
city: Yamato-shi
country: Japan
facility: Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: OCROM Clinic
state: Osaka
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Minato-ku, Tokyo
country: Japan
facility: Toranomon Hospital, Endocrinology and Metabolism
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Takatsuki Red Cross Hospital
city: Tokyo
country: Japan
facility: Tokyo Center Clinic
city: Tokyo
country: Japan
facility: ToCROM Clinic
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: