New Triple-Action weight loss drug enters first human safety tests
NCT ID NCT07205432
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new injection called XTL6001 in 80 healthy and obese adults. The main goal is to check safety and how the body processes the drug. Researchers will also look at weight changes, but the study is too small to prove effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XTL6001 injection (a triple-target GLP-1 receptor agonist for weight management)
- What this could lead to
- If successful, this could lead to a new injectable medication for weight loss and metabolic disease management.
- What could go wrong
- This is an early Phase 1 trial with only 80 participants, focused on safety. It is too small and early to know if XTL6001 will be effective or have serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion Criteria for Subjects in SAD part: 1. Age ≥ 18 and \< 65 years at screening. 2. Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening. 3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening. 4. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions. Inclusion Criteria for Subjects in MAD part: 1. Age ≥ 18 and \< 65 years at screening. 2. BMI ≥ 18.5 kg/m2且 \< 40.0kg/m². 3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening. 4. Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening. 5. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions. Exclusion Criteria: Exclusion Criteria for Subjects in SAD part: 1. History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening. 2. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery. 3. History of acute or chronic pancreatitis. 4. Symptomatic gallbladder disease. 5. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer). 6. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B). 7. Female subjects with positive pregnancy test or lactation. Exclusion Criteria for Subjects in MAD part: 1. History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening. 2. UnderlyingCushing's syndrome, hypothyroidism, PCOS,. 3. 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. 4. History of acute or chronic pancreatitis. 5. Symptomatic gallbladder disease. 6. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer). 7. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B). 8. Female subjects with positive pregnancy test or lactation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Shijitan Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100038, China