NCT04575194

Brief Summary

The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
Completed

Started Sep 2020

Typical duration for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

September 30, 2020

Last Update Submit

October 6, 2020

Conditions

ObesityBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • Changes in blood pressure

    Blood pressure as assessed by 24-hour recording (numerical scale)

    3 and 6 months

Secondary Outcomes (9)

  • Weight loss

    3 and 6 months

  • Changes in glycemic

    3 and 6 months

  • Changes in lipemic profile

    3 and 6 months

  • Percentage of visceral fat

    3 and 6 months

  • Fat mass

    3 and 6 months

  • +4 more secondary outcomes

Study Arms (2)

Liraglutide 3 mg

ACTIVE COMPARATOR

Patients will be prescribed sc liraglutide 3 mg/day along with a dietary and physical activity intervention.

Drug: Liraglutide 6 MG/ML [Saxenda]

Naltrexone/bupropion 32/360 mg

ACTIVE COMPARATOR

Patients will be prescribed oral naltrexone/bupropion 32/360 mg/day along with a dietary and physical activity intervention.

Drug: Naltrexone-Bupropion Combination

Interventions

Liraglutide 6 MG/ML [Saxenda]DRUG

3 mg of sc liraglutide daily plus lifestyle intervention

Liraglutide 3 mg
Naltrexone-Bupropion CombinationDRUG

32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention

Naltrexone/bupropion 32/360 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes.

You may not qualify if:

  • Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone
  • Bariatric surgery
  • Diabetes type 2
  • Active malignancy
  • Medication that affects weight (eg corticosteroids, phenothiazines)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Department of Propaedeutic Internal Medicine

Athens, 11527, Greece

RECRUITING

Related Publications (1)

  • Stefanakis K, Kokkinos A, Simati S, Argyrakopoulou G, Konstantinidou SK, Kouvari M, Kumar A, Kalra B, Mantzoros CS. Circulating levels of all proglucagon-derived peptides are differentially regulated postprandially by obesity status and in response to high-fat meals vs. high-carbohydrate meals. Clin Nutr. 2023 Aug;42(8):1369-1378. doi: 10.1016/j.clnu.2023.06.026. Epub 2023 Jun 28.

    PMID: 37418844DERIVED

MeSH Terms

Conditions

Obesity

Interventions

LiraglutideNaltrexone-Bupropion combination

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Alexandros Kokkinos, MD, PhD

    National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandros Kokkinos, MD, PhD

CONTACT

+302132061248rjd@otenet.gr

Georgia Argyrakopoulou, MD, PhD, MSc

CONTACT

+306972284033gargyrakopoulou@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 5, 2020

Study Start

September 8, 2020

Primary Completion

September 30, 2022

Study Completion

May 30, 2023

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)