NCT07205432RecruitingPhase 1
Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects
Source: ClinicalTrials.gov · Last updated 3 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Jul 2025
- Start date
- 13 Jun 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- Shanghai Xitaili Biomedicine Technology co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07205432
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 80
- From 13 Jun 2025 to the primary completion date, Apr 2026
- 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
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
Other illness
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
- UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise safety or data interpretation.
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
Lab values
- History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
- History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
Other
- Female subjects with positive pregnancy test or lactation.
- Female subjects with positive pregnancy test or lactation.
Who the study is looking for
- Age ≥ 18 and \< 65 years at screening.
- Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening.
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
- Age ≥ 18 and \< 65 years at screening.
- BMI ≥ 18.5 kg/m2且 \< 40.0kg/m².
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Shijitan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.