Clinical trial NCT05649137: A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
Official title: Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 513
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Semaglutide 7.2 mg versus Placebo: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
Secondary outcomes:
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in very-low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than (<) 7.0% (53 millimoles per mole [mmol/mol])
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than or equal to (<=) 6.5 % (48 mmol/mol)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Placebo: Change in pulse
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
timeFrame: From baseline (week 0) to end of study (week 81)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Concord
country: United States
facility: John Muir Physicians Network
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research Westlake
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Golden
country: United States
facility: New West Physicians PC
state: Colorado
city: DeLand
country: United States
facility: ARS- Deland CRU
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr for Clin Res
state: Florida
city: Orlando
country: United States
facility: Florida Inst For Clin Res LLC
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Conyers
country: United States
facility: Hope Clin Res & Wellness
state: Georgia
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Austin
country: United States
facility: Elligo Clin Res Centre
state: Texas
city: Dallas
country: United States
facility: Velocity Clin Res, Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Lingvay
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice PA
state: Texas
city: Richmond
country: United States
facility: National Clin Res Inc.
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Blagoevgrad
country: Bulgaria
facility: "MHAT-Blagoevgrad", Department of Internal Diseases
city: Burgas
country: Bulgaria
facility: ET "Individual practice for specialized outpatient medical care - Dr. Georgi Marinov"
city: Dobrich
country: Bulgaria
facility: "Medical Center Viva Feniks" Ood
city: Pazardzhik
country: Bulgaria
facility: UMHAT Pulmed, Department of endocrinology
city: Plovdiv
country: Bulgaria
facility: 'MHAT Sveta Karidad' EAD
city: Sliven
country: Bulgaria
facility: 'MHAT Hadzhi Dimitar' OOD
city: Sofia
country: Bulgaria
facility: "DCC VII - Sofia", Endocrinology Consulting Room
city: Stara Zagora
country: Bulgaria
facility: "UMHAT- Prof. dr. Stoyan Kirkovich"
city: Yambol
country: Bulgaria
facility: "MHAT "Sveti Panteleimon" - Yambol" AD
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Halifax
country: Canada
facility: Nova Scotia Hlth Halifax
state: Nova Scotia
city: Hamilton
country: Canada
facility: Premier Clinical Trial Research Network (PCTRN)
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Baja
country: Hungary
facility: Lausmed Kft.
state: Bács-Kiskun Vármegye
city: Debrecen
country: Hungary
facility: Belinus Bt.
state: Hajdu-Bihar Varmegye
city: Nyíregyháza
country: Hungary
facility: Borbánya Praxis E.Ü. Kft.
state: Szabolcs-Szatmar Varmegye
city: Budapest
country: Hungary
facility: ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: MED-TIMA Kft.
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Oktatókórház
city: Lublin
country: Poland
facility: NZOZ "CenterMed Lublin" Sp. z o.o.
state: Lubelskie
city: Lublin
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Medica
state: Lubelski
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Bialystok
country: Poland
facility: Kresmed Sp. z o. o.
state: Podlaskie
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne SUM w Katowicach
city: Warszawa
country: Poland
facility: NBR Polska Tomasz Klodawski
city: Warszawa
country: Poland
facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA
city: Senhora da Hora
country: Portugal
facility: Unidade Local de Saúde de Matosinhos
state: Matosinhos
city: Lisboa
country: Portugal
facility: APDP - Associação Protectora dos Diabéticos de Portugal
city: Porto
country: Portugal
facility: Centro Hospitalar de São João
city: Bardejov
country: Slovakia
facility: DIADA s.r.o.
city: Bardejov
country: Slovakia
facility: DIADA, s.r.o.
city: Bytca
country: Slovakia
facility: Diab - Int, s.r.o.
city: Kosice
country: Slovakia
facility: Diabetologicka ambulancia ENDOMED, s.r.o.
city: Povazska Bystrica
country: Slovakia
facility: MED-DIA CENTRUM s.r.o.
city: Presov
country: Slovakia
facility: DIABETOL, s.r.o.
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Medi-Clinic Bloemfontein
state: Free State
city: Johannesburg
country: South Africa
facility: Deepak Lakha
state: Gauteng
city: Johannesburg
country: South Africa
facility: Hemant Makan
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Bara Clinical Trial Site
state: Gauteng
city: Durban
country: South Africa
facility: Dr N.K. Gounden Medical Centre
state: KwaZulu Natal
city: Durban
country: South Africa
facility: Maxwell Centre
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
facility: Dr T Padayachee
state: KwaZulu-Natal
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: