DelfaGLP-1 Atlas

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ZYD1

CompletedPhase 1

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, a Selective Glucagon-like Peptide (GLP) 1 Agonist, Following Subcutaneous Administration in Healthy Volunteers.

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

56

actual

Study population

Healthy volunteers

Key I/E criterion

—

Primary endpoint

•Safety and tolerability of ZYD1

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01972893
Org study IDZYD1/1001
Secondary IDCTRI/2011/04/001684Clinical Trial Registration India

Timeline

Milestones

Study first posted2013-10-31estimated
Last update posted2013-10-31estimated
Study start2011-02 (month precision)
Primary completion2012-03actual (month precision)
Study completion2012-06actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Age: 18-45 years

2. Mentally, physically, and legally eligible to give informed consent

3. Male and female volunteers weighing between 50-75 kg and 45-75 kg respectively

4. Ability to communicate effectively with the study personnel

5. Willingness to adhere to the protocol requirements

6. For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting nonhormonal contraceptive measures (e.g., intrauterine device) will be recruited.

Exclusion criteria

1. Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYD1 formulation

2. Presence or history of pancreatitis at any time (Serum Amylase/Serum Lipase more than upper normal limit (UNL))

3. Presence or history of severe gastrointestinal disease in the last 6 months

4. Presence or history of renal insufficiency at any time (serum creatinine above the upper limit of the reference range)

5. Active liver disease and/or liver transaminases greater than 1.5 X UNL

6. Subject with personal or family history of medullary thyroid cancer

7. Subject with personal or family history of multiple endocrine neoplasia syndrome type 2

8. Subject with serum calcitonin >50 ng/L

9. History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)

10. Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT) tests on the day of check in

11. History or presence of any medication in the last 14 days including any medication known to interact with the Cytochrome P (CYP) 450 system

12. History or presence of significant alcoholism or drug abuse within the past 1 year

13. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)

14. Difficulty with donating blood

15. Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg

16. Pulse rate less than 60/minute and more than 100/minute

17. Any clinically significant abnormal X-ray or laboratory findings during screening

18. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening

19. Major illness and/or major surgery in last 3 months

20. Volunteers who have participated in any drug research study other than the present trial within past 3 months

21. Volunteers who have donated one unit (350 ml) of blood in the past 3 months

22. For gender effect study, female volunteers with following criteria will not be recruited:

–History of pregnancy or lactation in the past 3 months
–Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility device or history of less than 1 year of menopause
–Using hormonal contraceptives
–Using hormone replacement therapy
–Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
–Positive urine pregnancy test on the day of check-in

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

To evaluate Safety and tolerability of ZYD1

Time frame:21 days

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) and Pharmacodynamic (PD) effect after single and multiple subcutaneous dose administrations in healthy adult male volunteers Gender effect study.

Time frame:1. For Plan I and III - Pre-dose (before dosing), 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, 24, 48, 72 and 120 hrs post dose 2. Plan II - Day 01 - Pre-dose, 1, 2, 3, 4 and 8 hours following first dosing. Day 02 to 06 - Pre-dose of each . Day 07 - Pre-dose, 1, 2, 3,

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.