A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes

This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Semaglutide; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 513
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • "MHAT-Blagoevgrad", Department of Internal Diseases
  • Burgas, Bulgaria, 8000
    • ET "Individual practice for specialized outpatient medical care - Dr. Georgi Marinov"
  • Dobrich, Bulgaria, 9300
    • "Medical Center Viva Feniks" Ood
  • Pazardzhik, Bulgaria, 4400
    • UMHAT Pulmed, Department of endocrinology
  • Plovdiv, Bulgaria, 4004
    • 'MHAT Sveta Karidad' EAD
  • Sliven, Bulgaria, 8800
    • 'MHAT Hadzhi Dimitar' OOD
  • Sofia, Bulgaria, 1233
    • "DCC VII - Sofia", Endocrinology Consulting Room
  • Stara Zagora, Bulgaria, 6000
    • "UMHAT- Prof. dr. Stoyan Kirkovich"
  • Yambol, Bulgaria, 8600
    • "MHAT "Sveti Panteleimon" - Yambol" AD
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3Z 2N6
      • Ocean West Research Clinic
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G.A. Research Associates Ltd.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Hlth Halifax
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Med Clin Trials
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Med Res Group
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
• Hungary
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Kórház
  • Budapest, Hungary, 1089
    • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Budapest, Hungary, 1132
    • MED-TIMA Kft.
  • Székesfehérvár, Hungary, 8000
    • Fejér Megyei Szent György Oktatókórház
  • Bács-Kiskun Vármegye
    • Baja, Bács-Kiskun Vármegye, Hungary, 6500
      • Lausmed Kft.
  • Hajdu-Bihar Varmegye
    • Debrecen, Hajdu-Bihar Varmegye, Hungary, 4025
      • Belinus Bt.
  • Szabolcs-Szatmar Varmegye
    • Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary, 4405
      • Borbánya Praxis E.Ü. Kft.
• Poland
  • Katowice, Poland, 40-752
    • Uniwersyteckie Centrum Kliniczne SUM w Katowicach
  • Warszawa, Poland, 02-507
    • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • Warszawa, Poland, 00-710
    • NBR Polska Tomasz Klodawski
  • Lubelski
    • Lublin, Lubelski, Poland, 20-538
      • NZOZ Przychodnia Specjalistyczna Medica
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-044
      • NZOZ "CenterMed Lublin" Sp. z o.o.
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-261
      • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-481
      • Kresmed Sp. z o. o.
• Portugal
  • Lisboa, Portugal, 1250-230
    • APDP - Associação Protectora dos Diabéticos de Portugal
  • Matosinhos, Portugal, 4464-513
    • Unidade Local de Saúde de Matosinhos
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de São João
• Slovakia
  • Bardejov, Slovakia, 08501
    • DIADA s.r.o.
  • Bytca, Slovakia, 014 01
    • Diab - Int, s.r.o.
  • Kosice, Slovakia, 04013
    • Diabetologicka ambulancia ENDOMED, s.r.o.
  • Povazska Bystrica, Slovakia, 01701
    • MED-DIA CENTRUM s.r.o.
  • Presov, Slovakia, 080 01
    • DIABETOL, s.r.o.
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6001
      • Phoenix Pharma
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Medi-Clinic Bloemfontein
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1820
      • Deepak Lakha
    • Johannesburg, Gauteng, South Africa, 1827
      • Hemant Makan
    • Johannesburg, Gauteng, South Africa, 2013
      • Wits Bara Clinical Trial Site
  • KwaZulu Natal
    • Durban, KwaZulu Natal, South Africa, 4093
      • Dr N.K. Gounden Medical Centre
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4001
      • Maxwell Centre
    • Umkomaas, KwaZulu-Natal, South Africa, 4170
      • Dr T Padayachee
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • Univ of Alabama Birmingham
  • California
    • Concord, California, United States, 94520
      • John Muir Physician Network
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research Westlake
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Colorado
    • Golden, Colorado, United States, 80401
      • New West Physicians PC
  • Florida
    • DeLand, Florida, United States, 32720
      • ARS- Deland CRU
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Ctr For Clin Res
    • Orlando, Florida, United States, 32825
      • Florida Inst For Clin Res LLC
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research, LLC
  • Georgia
    • Conyers, Georgia, United States, 30094
      • Hope Clin Res & Wellness
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences LLC
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Med Spec LLP
    • Austin, Texas, United States, 78704
      • Elligo Clin Res Centre
    • Dallas, Texas, United States, 75230
      • Velocity Clin Res, Dallas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center - Lingvay
    • Houston, Texas, United States, 77079
      • PlanIt Research, PLLC
    • Longview, Texas, United States, 75605
      • DCOL Ctr for Clin Res
    • Sugar Land, Texas, United States, 77479
      • Sugar Lakes Family Practice PA
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clin Res Inc.
    • Winchester, Virginia, United States, 22601-3834
      • Selma Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female.
• Age above or equal to 18 years at the time of signing informed consent.
• BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
• Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
• HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

• A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.	Drug: Placebo; Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Experimental: Semaglutide 7.2 mg; Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.	Drug: Semaglutide; Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.; Drug: Semaglutide; Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
Experimental: Semaglutide 2.4 mg; Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.	Drug: Semaglutide; Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.; Drug: Semaglutide; Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semaglutide 7.2 mg versus Placebo: Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in waist circumference	Measured in centimeters (cm).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in body weight	Measured in kilograms (kg).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in total cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in triglycerides	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in free fatty acids	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose	Measured in milligrams per deciliter (mg/dL).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)	Measured in kilograms per square meter (kg/m^2).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in very-low-density lipoprotein (VLDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than (<) 7.0% (53 millimoles per mole [mmol/mol])	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than or equal to (<=) 6.5 % (48 mmol/mol)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Change in pulse	Measured in beats per minute (bpm).	From baseline (week 0) to end of treatment (week 72)
Semaglutide 7.2 mg versus Placebo: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes	Measured as count of episodes.	From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes	Measured as count of episodes.	From baseline (week 0) to end of study (week 81)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Estimated): October 4, 2024
• Study Completion (Estimated): December 6, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9536-7545; 2022-002235-60 (EudraCT Number); U1111-1279-0359 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No