Study S002375

A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04667377
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 387
Start: 2021-03-08
Primary completion: 2022-09-15
Lead sponsor: Boehringer Ingelheim
Conditions: Obesity
Interventions: DRUG:BI 456906; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2020-002479-37

Registered primary outcomes

Percentage Change in Body Weight From Baseline to Week 46 [Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.]

Linked records (7)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0005767	Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell Function and Insulin Sensitivity in People With Type 2 Diabetes or Living With Overweight/Obesity. Ekinci EI, Diabetes, obesity & metabolism	2026	Randomized trial	PMID 42331726 DOI	cites ClinicalTrials.gov:NCT04667377; cites EudraCT:2020-002479-37; registry reference DERIVED:42331726
R0015235	Subgroup analysis by sex and baseline BMI in people with a BMI ≥27 kg/m2 in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist. le Roux CW, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 39821928 DOI	cites ClinicalTrials.gov:NCT04667377; registry reference DERIVED:39821928
R0045020	S746 Pharmacogenomic Analysis of the GLP-1 Receptor in a Phase 2 Trial of Survodutide, a Glucagon/GLP-1 Receptor Dual Agonist, in Adults With Obesity Matthias Blüher, The American Journal of Gastroenterology	2025	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04667377
R0013517	Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. le Roux CW, The lancet. Diabetes & endocrinology	2024	Randomized trial	PMID 38330987 DOI	cites ClinicalTrials.gov:NCT04667377; cites EudraCT:2020-002479-37; registry reference DERIVED:38330987
R0049255	1665-P: Analysis of Glucose Biomarkers in Phase I and Phase II Studies of Survodutide in People with Type 2 Diabetes or Living with Overweight/Obesity Elif Ilhan Ekinci, Diabetes	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT04667377
R0052533	6926 Subgroup Analysis by Gender and Body Mass Index (BMI) in People Living With Overweight/Obesity in the Survodutide, a Glucagon/GLP-1 Receptor Dual Agonist, Phase II Trial Carel Wynand le Roux, Journal of the Endocrine Society	2024	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04667377
R0047550	51-OR: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of BI 456906 in People with Overweight/Obesity Carel Wynand le Roux, Diabetes	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04667377