An open-label, randomized, single oral dose, three-treatment, one period, parallel comparative bioavailability study of ANY-004 (Oral Tirzepatide 20 mg and 40 mg Tablet) of Anya Biopharm Inc., Taipei, Taiwan (T) with MOUNJARO (Tirzepatide) 2.5 mg Subcutaneous injection of Eli Lilly and Company, USA among healthy, adult male and/or females under fasting conditions.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000224325

Enrollment

Registered

2026-02-23

Start date

2026-03-16

Completion date

2026-03-18

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To study the comparison of the PK profiles of single doses of ANY- 004 (Oral Tirzepatide 20 mg and 40 mg Tablet) of Anya Biopharm Inc., Taipei, Taiwan (T) with single dose of MOUNJARO (Tirzepatide) 2.5 mg Subcutaneous injection of Eli Lilly and Company, USA among healthy, adult male and/or females under fasting conditions. To monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Tirzepatide formulations (Tablet and Subcutaneous injection) under fasting condition.

Interventions

Participants will receive a single dose of tirzepatide under fasting conditions as part of an open-label, randomized, parallel-group comparative bioavailability study. Test interventions: ANY-004 (Oral Tirzepatide) 20 mg tablet, single oral dose, or ANY-004 (Oral Tirzepatide) 40 mg tablet, single oral dose Participants will be randomized to one of the following parallel treatment arms: Arm 1: ANY-004 (Oral Tirzepatide) 20 mg tablet, single oral dose Arm 2: ANY-004 (Oral Tirzepatide) 40 mg tablet, single oral dose Arm 3 (Reference): MOUNJARO® (Tirzepatide) 2.5 mg subcutaneous injection, single dose Randomization will determine whether a participant receives the 20 mg oral tablet, the 40 mg oral tablet, or the reference subcutaneous injection. Each participant will receive one assigned treatment only during the study. The oral study medication will be administered on Day 1 after an overnight fast of at least 10 hours, together with 100 ± 2 mL of water. Tablets must be swallowed whole and not chewed, crushed, or broken. Dosing will be directly supervised by clinical staff, with mouth and hand checks performed to confirm ingestion. The exact dosing time will be recorded in the Case Report Form. Strategies to monitor adherence to the intervention As this is a single dose, supervised clinical study, adherence will be ensured by direct observation of dosing by trained clinical staff. Compliance will be confirmed through mouth and hand checks immediately after administration. No tablet return is applicable. Ongoing compliance and exposure will be indirectly assessed through scheduled pharmacokinetic blood sampling and participant confinement/ambulatory visit attendance as per protocol

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified. 1. Age: 18 or older 2. Gender: Male and/or non-pregnant, non-lactating female. A) Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test performed within 28 days prior to dosing day. They must be using an acceptable form of contraception (non-hormonal methods). B) For female of childbearing potential, acceptable forms of contraception include the following: i. Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study. C) Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level > 40 mIU/mL, or iii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv. Total hysterectomy and an absence of bleeding for at least 3 months. 3. BMI: 18.5 to 32.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 32.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4. Volunteers having body weight more than 45 kg. 5. Able to communicate effectively with study personnel. 6. Willing to provide written informed consent to participate in the study. 7. All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days study medication administration which will include: A) A physical examination (clinical examination) with no clinically significant finding. B) Results within normal limits or clinically non-significant for the following tests (units and reference ranges to be adopted as per site laboratory manual): Hematology: Hemoglobin, Total RBC count, Total WBC count, Platelet count Differential leukocyte count: Neutrophils, Lymphocytes, Eosinophils, Monocytes, Basophils, Blood indices: HCT Biochemistry: Serum creatinine Random glucose AST & ALT Alkaline phosphatase Serum bilirubin Serum total protein: Total proteins, Albumin Serum Lipase and Serum Amylase Urinalysis: Inclusive but not limited to: Color, quantity, specific gravity, odour, appearance, reaction, albumin, bilirubin, ketone bodies, sugar, urobilinogen and microscopical examination (performed based on clinical judgment and site protocol) Immunological Tests: HIV-I & II, HbsAg, Anti HCV Serum (ß-HCG) pregnancy test (for female of childbearing potential) Serum Follicular Stimulating Hormone (FSH) (if required) Additional Tests 12 Lead ECG Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion. All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.

Exclusion criteria

Volunteers must not be enrolled in the study if they meet any one of the following criteria: 1. History of allergic responses to tirzepatide or other related drugs, or any of its formulation ingredients. 2. Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, Serum (ß-HCG) pregnancy test (for female of childbearing potential) & Serum Follicular Stimulating Hormone (FSH-if required) (for female volunteers)]. 3. Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, endocrine, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system. 4. Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors. 5. Have a prior history of malignant disease(s) in the past 5 years prior to screening 6.. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 7 Use of any hormone replacement therapy within 3 months prior to study medication administration. 8. Use of any depot injection or implant of any drug within 3 months prior to study medication administration. 9. History or evidence of drug dependence or of alcoholism or of moderate alcohol use. 10. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period. 11. History of difficulty with donating blood or difficulty in accessibility of veins. 12. A positive hepatitis screen (includes subtypes B & C). 13. A positive test result for HIV antibody. 14 Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to study medication administration. 15. Volunteers who have participated in any trials within 90 days (excluding volume drawn at screening for this study) prior to study medication administration. 16. History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption. 17. Intolerance to venipuncture 18. Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study. 19. Institutionalized volunteers. 20. Use of any prescribed medications within 14 days prior to study medication administration. 21. Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to study medication administration. 22. Use of grapefruit and grapefruit containing products within 7 days prior to study medication administration. 23. Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine- containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to study medication administration. 24. Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to study medication administration.

Outcome results