GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295

A Two-Part First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of GUB014295 in Lean to Overweight or Obese But Otherwise Healthy Men and Women

Lead sponsor

AbbVie

Asset

ABBV-295

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 22-32•Healthy volunteers

Primary endpoints

•Treatment-emergent AEs (any)•Safety - changes in vital signs (Systolic BP, change, Diastolic BP, change, Heart rate, change)•Safety - Safety laboratory parameters

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 IDNCT06144684

Org study IDGUC17-01

Secondary ID1008236MHRA (IRAS)

Timeline

Milestones

Study first posted2023-11-22actual

Study start2023-11-29actual

Primary completion2026-01-05actual

Study completion2026-01-05actual

Last update posted2026-01-15actual

Assets

Investigational agents

ABBV-295

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Males (Part 1 only) aged 18 to 55 years, and males and females (Part 2 only) aged 18 to 65 years inclusive at the time of signing informed consent

•Must agree to adhere to the contraception requirements

•Lean to overweight or obese but otherwise healthy males (Part 1 and 2) or nonpregnant, non-lactating females (Part 2 only)

•BMI of 22.0 to 32.0 kg/m2 for Part 1 and Part 2A, and a BMI of 27.0 to 35.0 kg/m2 for Part 2B and Part 2C, as measured at screening. Overweight or obese as assessed by BMI should be due to excess adipose tissue, as judged by the investigator

•Weight for males ≥70 kg (all parts), and for females ≥60 kg (Part 2 only) at screening

Exclusion criteria

•Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients

•Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active

•Known or suspected hypersensitivity or allergy to paracetamol

•Presence or history of clinically significant cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, haematological or venereal disorder, as judged by the investigator

•Presence or history of any clinically relevant gastrointestinal diseases or symptoms of gastrointestinal disorders potentially affecting interpretation of study data.

•Presence or history of diseases associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)

•History of major depressive disorder within 2 years prior to screening

•Subjects unable to take paracetamol for any reason

•Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening

•Subjects with tattoos or scars on the abdomen which may interfere with injection site assessments as determined by the investigator or delegate at screening

•Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.

•HbA1c ≥48 mmol/mol (≥6.5%) and/or fasting plasma glucose ≥7.0 mmol/L at screening

•Part 2B only: Subjects with haemoglobin <LLN at screening and/or admission

•Prolongation of the QTcF over 450 msec for males and 470 msec for females or any other clinically significant abnormal ECG results as judged by the investigator

•Supine blood pressure (after ≥5 min rest) <90 mmHg or >150 mmHg (systolic) and/or <50 mmHg or >90 mmHg (diastolic)

•Heart rate (ECG-recorded after ≥5 min rest) <45 or >90 beats per minute

•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results

•Evidence of renal impairment at screening, as indicated by an estimated glomerular filtration rate (eGFR) of <70 mL/min/1.73m2

•Part 2 only: Females who are pregnant or lactating (all female subjects must have a negative highly sensitive urine or serum pregnancy test)

•Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer

•Subjects who have previously been administered IMP in this study

•Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood

•Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies/vitamins in the 14 days before IMP administration.

•Paracetamol (up to 4 g per day) will be permitted except in the 48 h prior to the mixed meal tests on Day -1 and Day 4 (Part 1 Cohorts 2 to 6), Day 39 (Part 2A) and Day 81 (Part 2B) where paracetamol is not permitted.

•NSAIDs can be given at the discretion of the investigator to treat any AEs if necessary;

•Subject reports prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months

•History of any drug or alcohol abuse in the past 2 years

•Regular alcohol consumption >21 units per week and in females >14 units per week

•A confirmed positive alcohol breath test at screening or admission

•Current smokers and those who have smoked within the last 12 months

•Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

•A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission

•Confirmed positive drugs of abuse test result at screening or admission

•Anticipated change in lifestyle (such as eating, exercise or sleeping pattern) during the trial and/or clinically significant body weight change (≥5% self-reported change) or comprehensive dieting attempts (e.g. participation in a weight reduction program or treatment with any medication indicated for weight management) within the last 90 days prior to screening

•Subjects who do not agree to consume the liquid mixed meal

•Male subjects with pregnant or lactating partners

•Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, that the investigator evaluates might jeopardise the subject's safety or compliance with the protocol

Endpoints (10)

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.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Other/protocol endpoint

Pharmacodynamic - body weight

Time frame:From baseline (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Other/protocol endpoint/low confidence

Pharmacodynamic - liquid meal test incl. paracetamol (Part 1, Part 2A & Part 2B)

Time frame:Before dosing (day -1) and day 4 part 1, day-1 and day 39 part 2A and day-1 and day 81 part 2B

ratio, descriptive

componentsPostprandial glucose, C-peptide AUC

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Safety - Adverse Events (AE) incidence

Time frame:from baseline (day 0) to end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Safety - changes in vital signs

Time frame:from baseline (day 0) to end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

ratio, descriptive

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Primary/protocol endpoint

Safety - Safety laboratory parameters

Time frame:From baseline (day 0) to end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) - Tmax and Cmax

Time frame:from dosing (day 0) until maximum concentration after final dose

Tmax

concentration, descriptive

componentsTmax, Cmax

Secondary/protocol endpoint

Pharmacokinetic (PK) - area under the concentration curve (AUC)

Time frame:From dosing (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) - T1/2

Time frame:from dosing (day 0) until end of trial (day 29)part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) - CL/F

Time frame:from dosing (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

descriptive

Secondary/protocol endpoint

Pharmacokinetic (PK) - Vz/F

Time frame:From dosing (day 0) until end of trial (day 29) part 1, (day 64) part 2A, (day 120) part 2B and (day 127) in Part 2C

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.