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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05649137
• Other study ID #: NN9536-7545
• Secondary ID: 2022-002235-60U1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 4, 2023
• Est. completion date: December 6, 2024

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 513
• Est. completion date: December 6, 2024
• Est. primary completion date: October 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Bulgaria	"MHAT-Blagoevgrad", Department of Internal Diseases	Blagoevgrad
Bulgaria	ET "Individual practice for specialized outpatient medical care - Dr. Georgi Marinov"	Burgas
Bulgaria	"Medical Center Viva Feniks" Ood	Dobrich
Bulgaria	UMHAT Pulmed, Department of endocrinology	Pazardzhik
Bulgaria	'MHAT Sveta Karidad' EAD	Plovdiv
Bulgaria	'MHAT Hadzhi Dimitar' OOD	Sliven
Bulgaria	"DCC VII - Sofia", Endocrinology Consulting Room	Sofia
Bulgaria	"UMHAT- Prof. dr. Stoyan Kirkovich"	Stara Zagora
Bulgaria	"MHAT "Sveti Panteleimon" - Yambol" AD	Yambol
Canada	Nova Scotia Hlth Halifax	Halifax	Nova Scotia
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	Milestone Research	London	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Ocean West Research Clinic	Surrey	British Columbia
Hungary	Lausmed Kft.	Baja	Bács-Kiskun Vármegye
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.	Budapest
Hungary	MED-TIMA Kft.	Budapest
Hungary	Belinus Bt.	Debrecen	Hajdu-Bihar Varmegye
Hungary	Borbánya Praxis E.Ü. Kft.	Nyíregyháza	Szabolcs-Szatmar Varmegye
Hungary	Fejér Megyei Szent György Oktatókórház	Székesfehérvár
Poland	Kresmed Sp. z o. o.	Bialystok	Podlaskie
Poland	Uniwersyteckie Centrum Kliniczne SUM w Katowicach	Katowice
Poland	Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET	Krakow	Malopolskie
Poland	NZOZ "CenterMed Lublin" Sp. z o.o.	Lublin	Lubelskie
Poland	NZOZ Przychodnia Specjalistyczna Medica	Lublin	Lubelski
Poland	NBR Polska Tomasz Klodawski	Warszawa
Poland	PANSTWOWY INSTYTUT MEDYCZNY MSWiA	Warszawa
Portugal	APDP - Associação Protectora dos Diabéticos de Portugal	Lisboa
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos
Portugal	Centro Hospitalar de São João	Porto
Slovakia	DIADA s.r.o.	Bardejov
Slovakia	Diab - Int, s.r.o.	Bytca
Slovakia	Diabetologicka ambulancia ENDOMED, s.r.o.	Kosice
Slovakia	MED-DIA CENTRUM s.r.o.	Povazska Bystrica
Slovakia	DIABETOL, s.r.o.	Presov
South Africa	Medi-Clinic Bloemfontein	Bloemfontein	Free State
South Africa	Dr N.K. Gounden Medical Centre	Durban	KwaZulu Natal
South Africa	Maxwell Centre	Durban	KwaZulu-Natal
South Africa	Deepak Lakha	Johannesburg	Gauteng
South Africa	Hemant Makan	Johannesburg	Gauteng
South Africa	Wits Bara Clinical Trial Site	Johannesburg	Gauteng
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	Dr T Padayachee	Umkomaas	KwaZulu-Natal
United States	Amarillo Med Spec LLP	Amarillo	Texas
United States	Elligo Clin Res Centre	Austin	Texas
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	John Muir Physicians Network Clinical Research Center	Concord	California
United States	Hope Clin Res & Wellness	Conyers	Georgia
United States	UT Southwestern Medical Center - Lingvay	Dallas	Texas
United States	Velocity Clin Res, Dallas	Dallas	Texas
United States	ARS- Deland CRU	DeLand	Florida
United States	New West Physicians PC	Golden	Colorado
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	PlanIt Research, PLLC	Houston	Texas
United States	Jacksonville Ctr for Clin Res	Jacksonville	Florida
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Velocity Clinical Research Westlake	Los Angeles	California
United States	Florida Inst For Clin Res LLC	Orlando	Florida
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	National Clin Res Inc.	Richmond	Virginia
United States	Sugar Lakes Family Practice PA	Sugar Land	Texas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  Poland,  Portugal,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semaglutide 7.2 mg versus Placebo: Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in waist circumference	Measured in centimeters (cm).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in body weight	Measured in kilograms (kg).	From baseline (week 0) to end of treatment (week 72)
Secondary	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)
Secondary	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)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 72)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in triglycerides	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)