A Phase 1 interventional study of CG-0416 in Overweight and Obesity, sponsored by HongKong Curegene Innovation Co., Limited. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by HongKong Curegene Innovation Co., Limited · Phase 1, Interventional, and Treatment
Among 187 studies in Obesity with a site in Australia — 56 open to participants now, 74 under way, 34 of them phase 3. Obesity · Australia.
Among the 187 studies in Obesity with a site in Australia, this one is the 117th largest by planned enrollment of the 168 interventional ones that give a count, is one of 40 that started in 2026, is one of 32 in phase 1, reaches primary completion later than 18 of the 73 other live ones, and was the 175th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →56 of the 187 studies in Obesity with a site in Australia are open now. Recruiting first, the newest first:
Pfizer · Sites in Australia, United States
AstraZeneca · Sites in Australia, United States, Argentina and 13 more countries
AstraZeneca · Sites in Australia, United States, Argentina and 13 more countries
Amgen · Sites in Australia, United States, Canada and 2 more countries
Verdiva Bio Dev Limited · Sites in Australia
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 37 · Phase 2 34 · Phase 3 59 · Phase 4 8
First in 1995; this study’s year is marked. 40 started in 2026.
This study's planned enrollment of 64 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 184 across the 168 interventional studies, 626 across the 19 observational. Of the 96 that completed or were terminated, 14 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
129 of 187 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with HongKong Curegene Innovation Co., Limited as lead sponsor.
HongKong Curegene Innovation Co., Limited has 1 study filed under Obesity — fewer than ten, so there is no comparison to draw.
24 of the studies in Obesity with a site in Australia that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07220642Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | 2027-05-11 |
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT05556512Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity | 2027-10 |
Among the 187 studies in Obesity with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Limited is developing the study drug CG-0416 as a potential new treatment for overweight and obesity. The purpose of this research is to investigate the safety, tolerability (if any side effects occur), pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body), of single and multiple oral doses of a study drug called CG-0416.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 64 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with HongKong Curegene Innovation Co., Limited as lead sponsor.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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:
Participant meets any of the following:
Any of the following abnormalities on the 12-lead at screening:
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a single dose of CG-0416 or placebo
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a low dose of CG-0416 or placebo once daily for 14 consecutive days.
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a middle dose of CG-0416 or placebo once daily for 14 consecutive days.
Drug: CG-0416
8 healthy participants will be randomly assigned in a ratio of 3:1 to receive a high dose of CG-0416 or placebo once daily for 14 consecutive days.
Drug: CG-0416
CG-0416 is a novel selective, liver-directed thyroid hormone receptor beta (THR-β) agonist, given orally once daily.
To determine number of participants with treatment-related adverse events as assessed by CTCAE v6.0 of single dose and multiple doses of CG-0416 in healthy participants.
Number of Incidence and frequency of adverse events (AEs) / SAEs possibly or probably related to study drug.
Time frame: up to 3 weeks
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants
Concentration changes from baseline in clinical laboratory safety tests: thyroid hormones \[TH\] , thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4)\], follicle-stimulating hormone (FSH), luteinizing hormone, estradiol, testosterone, and free testosterone.
Time frame: up to 3 weeks
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants.
Baseline and placebo-corrected QTcF (ΔΔQTcF).
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last).
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Area under the concentration-time curve from time 0 to theoretical infinity (AUC0-inf).
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
peak concentration (Cmax).
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time to peak concentration (Tmax).
Time frame: up to 3 weeks
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Terminal elimination half-life (T1/2).
Time frame: Up to 3 weeks
To assess pharmacodynamic (PD) parameters
Concentration changes from baseline in fasting blood apolipoprotein B (ApoB), lipoprotein (a) \[Lp(a)\], low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG)
Time frame: up to 3 weeks
To assess pharmacodynamic (PD) parameter insulin
Concentration changes from baseline in insulin
Time frame: up to 3 weeks
To assess pharmacodynamic (PD) parameter sex hormone binding globulin (SHBG)
Concentration changes from baseline in sex hormone binding globulin (SHBG).
Time frame: up to 3 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Mar 2027, 8 months later.
Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 8 months is below that.
Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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