NCT06147544CompletedPhase 1/2
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.
A Single Center, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.
Source: ClinicalTrials.gov · Last updated 19 Apr 2024
Brief summary (registry, in English)
The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 9 Aug 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- PegBio Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT06147544
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 36
- From 6 Jul 2023 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
- Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
Other illness
- History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
- History of multiple endocrine neoplasia syndrome type 2 (MEN-2) or medullary thyroid carcinoma (MTC).
- History of bariatric surgery for weight loss 1 year before screening.
Lab values
- FPG ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
- FPG \<3.9 mmol/L at screening and/or a history of hypoglycemia.
- PR intervals \> 210 msec and/or QRS wave group time limit \> 120 msec and/or Corrected QT interval using Fridericia's formula（QTcF）\> 450 msec at screening or randomization.
- Serum amylase or lipase \> 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
- Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
Other
- Abnormal Thyroid-Stimulating Hormone(TSH), free triiodothyronine(FT3), Free thyroxine(FT4) or diagnosed thyroid dysfunction
- Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening or randomization.
Who the study is looking for
- Chinese male or female subjects aged 18-60 years (both inclusive).
- Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI) ≥28.0 kg/m2 at screening.
- Weight change \<5% in the past 3 months before screening.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.