STEP-1: Research study investigating how well semaglutide works in people suffering from overweight or obesity

Phase 3

Active, not recruiting

• Conditions: Overweight, obesity and other hyperalimentation,

• Registration Number: CTRI/2018/07/014765
• Lead Sponsor: Novo Nordisk AS

Brief Summary

This is a 68-week, randomised, double-blind, placebo-controlled, two-armed, parallel group, multi-centre, multinational clinical trial comparing semaglutide s.c. 2.4 mg once-weekly with semaglutide placebo once-weekly in subjects with overweight or obesity.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-23
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 1950

Inclusion Criteria

• Informed consent obtained before any trial-related activities.
• Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2.
• Male or female, age ≥ 18 years at the time of signing informed consent 3.
• Body mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease 4.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

• Subjects are excluded from the trial if any of the following criteria apply: Glycaemia-related: 1.
• HbA1c ≥ 48 mmol/mol (6.5%) as measured by the central laboratory at screening 2.
• History of type 1 or type 2 diabetes mellitus 3.
• Treatment with glucose-lowering agent(s) within 90 days before screening 4.
• Obesity-related: 5.
• A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records 6.
• Treatment with any medication for the indication of obesity within the past 90 days before screening 7.
• Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device.
• However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening 8.
• Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L as measured by the central laboratory at screening.
• Mental health: 9.
• Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) 11.
• A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening 12.
• A lifetime history of a suicidal attempt 13.
• Suicidal behaviour within 30 days before screening 14.
• Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening.
• General safety: 15.
• Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening 16.
• Presence of acute pancreatitis within the past 180 days prior to the day of screening 17.
• History or presence of chronic pancreatitis 18.
• Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma 20.
• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR < 15 ml/min/1.73 m2 as defined by KDIGO 201268 by the central laboratory at screening 21.
• History of malignant neoplasms within the past 5 years prior to screening.
• Basal and squamous cell skin cancer and any carcinoma in-situ are allowed 22.
• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening 23.
• Subject presently classified as being in New York Heart Association (NYHA) Class IV 24.
• Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator 25.
• Known or suspected abuse of alcohol or recreational drugs 26.
• Known or suspected hypersensitivity to trial product(s) or related products 27.
• Previous participation in this trial.
• Participation is defined as signed informed consent 28.
• Other subject(s) from the same household participating in any semaglutide trial 30.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 31.
• Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change from baseline at week 0 to week 68 in body weight (%)	68 Weeks
2. Subjects who after 68 weeks achieve (yes/no):	68 Weeks
3. Body weight reduction ≥ 5% from baseline at week	68 Weeks

Secondary Outcome Measures

Name	Time	Method
Subjects who after 68 weeks achieve	1.Body weight reduction ≥ 10% from baseline at week 0 (68 Weeks)
Change from baseline at week 0 to week 68	1. Waist circumference (cm) (68 Weeks)

Trial Locations

Locations (17)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Apollo Gleneagles Hospitals; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Chellaram Diabetes Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Deenanath Mangeshkar Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Endolife Speciality Hospital Pvt Ltd; 🇮🇳 Guntur, ANDHRA PRADESH, India

Government Medical College; 🇮🇳 Kozhikode, KERALA, India

Government Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Indian Institute of Diabetes; 🇮🇳 Thiruvananthapuram, KERALA, India

Scroll for more (7 remaining)

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Yashdeep gupta

Principal investigator

9999598468

yash_deep_gupta@yahoo.co.in