The TQF3250 clinical trial is an early-phase study of oral capsules in adults with type 2 diabetes and overweight or obesity. Its registered Phase 1b design focuses on safety, tolerability, how the drug moves through the body and preliminary effects. A trial record describes planned research; it does not demonstrate that the treatment works.

TQF3250 Phase 1b trial: design and objectives

This multicentre, randomised, double-blind, placebo-controlled trial aims to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of multiple oral doses of TQF3250. The study plans to enrol 72 eligible adult participants aged between 18 and 70 years. Participants are assigned to investigational-drug or placebo groups under the study protocol. These trial procedures are not a self-treatment schedule.

Safety, pharmacokinetics and HbA1c outcomes

Primary outcomes focus on the incidence and severity of adverse events, including serious and treatment-emergent adverse events, as well as abnormal clinical examination findings such as laboratory tests, vital signs, and electrocardiogram results. Secondary outcomes include pharmacokinetic parameters like area under the curve (AUC), maximum plasma concentration (Cmax), elimination half-life, and steady-state concentrations. Additionally, clinical markers such as glycated haemoglobin (HbA1c), oral glucose tolerance test results, body weight, waist circumference, body mass index (BMI), fasting plasma glucose, C-peptide, and insulin levels will be monitored.

Participant Eligibility and Considerations

Eligible participants must meet the 1999 World Health Organization diagnostic criteria for type 2 diabetes with overweight or obesity and be willing to comply with study procedures, including self-monitoring of blood glucose and adherence to a diabetic diet and exercise programme. Exclusion criteria include other forms of diabetes, recent acute diabetic complications, severe hypoglycaemia history, certain diabetic complications, and other medical conditions that could interfere with drug metabolism or study assessments.

How to read the TQF3250 trial record

ClinicalTrials.gov lists this study as NCT07747857. The record retrieved on 8 September 2026 showed recruiting status, an estimated 72 participants and an actual start date of 25 August 2026. Recruitment status can change; check the registry rather than relying on the age of this article.

The protocol names outcomes such as adverse events and drug-exposure measurements. Those outcomes are questions the trial intends to answer, not results already achieved. Eligibility is decided by the study team; a mention of a trial is not an offer of a Svelta product or clinical treatment.

Related reading

Explore understanding HbA1c, GLP-1 receptor agonists.

Sources

ClinicalTrials.gov: NCT07747857 — https://clinicaltrials.gov/study/NCT07747857