NCT02690987: GHADD

Do Appetitive Gut Hormones Reduce Addictive and Eating Behaviours in Obesity, and Nicotine and Alcohol Dependence?

Status unknown EARLY_PHASE1 Last updated 11 February 2020

What this trial tests

EARLY_PHASE1 trial testing Exenatide in Obesity in 95 participants. Status unknown.

Timeline

1 August 2015

Primary endpoint
21 August 2019

1 August 2020

Quick facts

Lead sponsor	Imperial College London
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	95
Start date	1 August 2015
Primary completion	21 August 2019
Estimated completion	1 August 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Exenatide (EXENATIDE) — full drug profile →
• Desacyl ghrelin — full drug profile →
• Saline

Conditions studied

• Obesity — all drugs for Obesity →
• Smoking Cessation — all drugs for Smoking Cessation →
• Alcoholism — all drugs for Alcoholism →

Sponsor

Imperial College London

Who can join

Adults 18 to 60, any sex, with Obesity or Smoking Cessation. Healthy volunteers can join.

What's being measured

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

• Functional MRI measure of brain activation during cigarette, alcohol and food picture evaluation task
  Time frame: 4 years
  Blood oxygen level dependent (BOLD) signal in brain reward systems to cigarette, alcohol and food pictures vs. object pictures

Sponsor's own description

The "Gut Hormones in Addiction" study is a proof-of-concept experimental medicine human study to answer the following questions:

1. Does the administration of the hormone desacyl ghrelin reduce core behavioural components of addiction in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects?
2. Does the administration of the drug Exenatide reduce core behavioural components of addiction in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects?
3. Does the administration of desacyl ghrelin or Exenatide reduce reward responses to high-calorie foods and appetite in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects?

Publications & conference data

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

1. The role of glucagon-like peptide 1 (GLP-1) in addictive disorders.
   Klausen MK, Thomsen M, Wortwein G, Fink-Jensen A. · · 2022 · cited 178× · PMID 34532853 · DOI 10.1111/bph.15677
2. Central and peripheral actions of nicotine that influence blood glucose homeostasis and the development of diabetes.
   Chen Z, Liu XA, Kenny PJ. · · 2023 · cited 26× · PMID 37482325 · DOI 10.1016/j.phrs.2023.106860
3. Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)-a structured summary of a study protocol for a randomized controlled study.
   Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, et al · · 2023 · cited 15× · PMID 37081574 · DOI 10.1186/s13063-023-07164-9
4. Ecological momentary assessment and cue-elicited drug craving as primary endpoints: study protocol for a randomized, double-blind, placebo-controlled clinical trial testing the efficacy of a GLP-1 receptor agonist in opioid use disorder.
   Freet CS, Evans B, Brick TR, Deneke E, et al · · 2024 · cited 10× · PMID 39061093 · DOI 10.1186/s13722-024-00481-7
5. Efficacy and Safety of Glucagon-Like Peptide-1 Agonists for Psychiatric Symptoms: A Systematic Review.
   Meshkat S, Di Luciano C, Swiderski A, Li G, et al · · 2025 · cited 3× · PMID 40635383 · DOI 10.1002/brb3.70661
6. Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov.
   Patil S, Jha N, Jha MK. · · 2026 · PMID 41696398 · DOI 10.1016/j.abrep.2026.100671