Study S003063

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT04855292
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 48
Start: 2021-07-01
Primary completion: 2022-12-01
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Conditions: Diabetes
Interventions: DRUG:TG103 injection; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Safety and tolerability assessed by incidence and severity of adverse events [Up to 99 days]

Linked records (1)

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
R0022276	Safety, tolerability, pharmacokinetics, and pharmacodynamics of TG103 injection in participants who are overweight or obese: a randomized, double-blind, placebo-controlled, multiple-dose phase 1b study. Lin D, BMC medicine	2024	Randomized trial	PMID 38807146 DOI	cites ClinicalTrials.gov:NCT04855292; registry reference DERIVED:38807146