A Phase 1 interventional study of LAE102 intravenous administration and placebo intravenous administration in Overweight and Obese Volunteers, sponsored by Laekna Limited. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Laekna Limited · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
Part A is a randomized, double-blinded, placebo-controlled, single ascending dose by Intravenous (IV) administration in 40 Healthy participants;
Part B is a randomized, double-blinded, placebo-controlled, single ascending dose by subcutaneous (SC) administration in 24 Healthy participants;
Part C is a randomized, double-blind, placebo-controlled, multiple dose ascending and expanding by subcutaneous (SC) administration in 60 overweight/obese participants.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 160 is above the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Laekna Limited is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose LAE102 by IV administration
Drug: LAE102 intravenous administration
Single dose placebo by IV administration
Drug: placebo intravenous administration
Single dose LAE102 by SC administration
Drug: LAE102 subcutaneous administration
Single dose placebo by SC administration
Drug: placebo subcutaneous administration
Multiple dose LAE102 by SC administration
Drug: LAE102 multiple subcutaneous administration
Multiple dose placebo by SC administration
Drug: Placebo multiple subcutaneous administration
A single dose of LAE102 administered intravenously
Also known as: LAE102 IV
A single dose of placebo administered intravenously
Also known as: Placebo IV
Single dose of LAE102 administered subcutaneously
Also known as: LAE102 SC
single dose of placebo administered subcutaneously
Also known as: Placebo SC
Multiple dose of LAE102 administered subcutaneously
Also known as: LAE102 SC
Multiple dose of placebo administered subcutaneously
Also known as: Placebo SC
Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0
Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0
Time frame: From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part
characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects
For both intravenously guttae \& subcutaneous injection, to evaluate the maximum observed serum concentration(Cmax)
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects
For both intravenously guttae \& subcutaneous injection, to evaluate the area under the serum concentration versus time curve (AUC)
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
evaluate the expression levels of Activin A in blood samples
The validated methodology was employed to assay serum levels of Activin A in biological samples.
Time frame: From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Incidence of positive Anti-drug antibody(ADA) after administration
Test ADA status in biological sample via validated methodology
Time frame: pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
Preliminary pharmacodynamic of total body weight for multiple dose part
Changes and percentage changes in total body weight (kg) after administration
Time frame: From pre-dose to Day 168.
Preliminary pharmacodynamic of lean mass for multiple dose part
Changes and percentage changes in lean mass after administration
Time frame: From pre-dose to Day 168.
Preliminary pharmacodynamic of fat mass for multiple dose part
Changes and percentage changes in fat mass after administration
Time frame: From pre-dose to Day 168.
Preliminary pharmacodynamic of thigh muscle volume for multiple dose part
Changes and percentage changes in thigh muscle volume after administration
Time frame: From pre-dose to Day 168
Preliminary pharmacodynamic of bone mineral density(BMD) for multiple dose part
Changes and percentage changes in BMD after administration
Time frame: From pre-dose to Day 168
BMI/waist circumference change and percentage.
Assess the Body Mass Index (BMI)/waist circumference change and percentage.
Time frame: From pre-dose to Day 29 forsingle dose. From pre-dose to Day 196 for multiple dose.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Sep 2026, 27 months after the start.
Of 211 industry-sponsored phase 1 interventional studies under Overweight, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 27 months is above that.
Counting every sponsor, half of 230 studies reached it within 9 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: LAE102
Laekna Limited