NCT04122716: S-LITE

Synergy Effect of the Appetite Hormone GLP-1 (LiragluTide) and Exercise on Maintenance of Weight Loss and Health After a Low Calorie Diet - the S-LiTE Randomized Trial

Status unknown Phase 4 Last updated 28 October 2020

What this trial tests

Phase 4 trial testing Liraglutide in Obesity in 215 participants. Status unknown.

Timeline

1 September 2016

Primary endpoint
1 November 2019

1 November 2021

Quick facts

Lead sponsor	Signe Torekov
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	215
Start date	1 September 2016
Primary completion	1 November 2019
Estimated completion	1 November 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Liraglutide (liraglutide) — full drug profile →
• Exercise

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Signe Torekov — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Body weight change (kg)
  Time frame: Change from baseline to end-of-treatment (52 weeks)
  Weight will be measured to the nearest 0.1 kg. The same set of scales should ideally be used throughout the trial. Weight should be measured in a fasting state without shoes and wearing light clothes.

Sponsor's own description

Introduction: The success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by one-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise, or the combination of both treatments as compared with placebo in individuals with obesity.

Methods and analysis: This is an investigator-initiated, randomized, placebo-controlled, parallel group trial. The investigators will enroll women and men (age 18 to 65 years) with obesity (body mass index 32 to 43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for eight weeks in order to lose at least 5 % of body weight. Subsequently, participants will be randomized in a 1:1:1:1 ratio to one of four study groups for 52 weeks: 1) placebo, 2) exercise 150 min/week + placebo, 3) liraglutide 3.0 mg/day, and 4) exercise 150 min/week + liraglutide 3.0 mg/day. Re-screening is allowed within the recruitment period.

The primary endpoint is change in body weight from randomization to end-of-treatment.

Ethics and dissemination: The trial has been approved by the ethical committee of the Capital Region of Denmark (H-16027082) and the Danish Medicines Agency (EudraCT 2015-005585-32). The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined.
   Lundgren JR, Janus C, Jensen SBK, Juhl CR, et al · · 2021 · cited 344× · PMID 33951361 · DOI 10.1056/nejmoa2028198
2. Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial.
   Jensen SBK, Blond MB, Sandsdal RM, Olsen LM, et al · · 2024 · cited 121× · PMID 38544798 · DOI 10.1016/j.eclinm.2024.102475
3. Combination of exercise and GLP-1 receptor agonist treatment reduces severity of metabolic syndrome, abdominal obesity, and inflammation: a randomized controlled trial.
   Sandsdal RM, Juhl CR, Jensen SBK, Lundgren JR, et al · · 2023 · cited 96× · PMID 36841762 · DOI 10.1186/s12933-023-01765-z
4. The Related Metabolic Diseases and Treatments of Obesity.
   Yang M, Liu S, Zhang C. · · 2022 · cited 89× · PMID 36141228 · DOI 10.3390/healthcare10091616
5. Sperm count is increased by diet-induced weight loss and maintained by exercise or GLP-1 analogue treatment: a randomized controlled trial.
   Andersen E, Juhl CR, Kjøller ET, Lundgren JR, et al · · 2022 · cited 57× · PMID 35580859 · DOI 10.1093/humrep/deac096
6. Exploratory analysis of eating- and physical activity-related outcomes from a randomized controlled trial for weight loss maintenance with exercise and liraglutide single or combination treatment.
   Jensen SBK, Janus C, Lundgren JR, Juhl CR, et al · · 2022 · cited 28× · PMID 35970829 · DOI 10.1038/s41467-022-32307-y
7. Insufficient sleep predicts poor weight loss maintenance after 1 year.
   Bogh AF, Jensen SBK, Juhl CR, Janus C, et al · · 2023 · cited 11× · PMID 36472579 · DOI 10.1093/sleep/zsac295
8. Weight-loss maintenance is accompanied by interconnected alterations in circulating FGF21-adiponectin-leptin and bioactive sphingolipids.
   Fiorenza M, Checa A, Sandsdal RM, Jensen SBK, et al · · 2024 · cited 9× · PMID 38959886 · DOI 10.1016/j.xcrm.2024.101629