Healthy VolunteersPhase 1NCT06144684

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

A Phase 1 study testing GUB014295 in people with Healthy Volunteers and Overweight, run by AbbVie at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Overweight
What is being tested?: GUB014295
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteUnited Kingdom
Study dates: 29 Nov 2023to 5 Jan 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 37Show fewer

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Sciences
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: 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

This is a two-part, single centre, double-blind (within cohorts), randomised, placebo-controlled, single (Part 1) and multiple (Part 2) ascending subcutaneous dose study in lean to overweight or obese but otherwise healthy men (Part 1) and men and non-pregnant, non-lactating women (Part 2). The primary objective is to assess the safety and tolerability. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate pharmacodynamic effects.

Read the detailed description

This is a phase 1 clinical trial of a new long-acting amylin analogue GUB014295 in two parts.

Trial design: Part 1 is a double-blind (within cohorts), randomised, placebo-controlled, single ascending dose (SAD) study. It is planned to enrol 4 cohorts of 8 subjects (Regimens A, B, C and D), with 2 additional optional cohorts of 8 subjects (Regimens E and F). Part 2A is a double-blind (within cohorts), randomised, placebo-controlled, multiple ascending dose (MAD) study. It is planned to enrol 2 cohorts of 8 subjects (Regimens G and H). Part 2B is a double-blind (within cohorts), randomised, placebo-controlled, MAD study.

It is planned to enrol 3 cohorts of 12 subjects (Regimens I, J and K). Part 2C is a double-blind (within cohorts), randomised, placebo-controlled, MAD study. It is planned to enrol 2 cohorts of up to 12 subjects (Regimens L and M).

The primary objective is to assess the safety and tolerability of a new long-acting amylin-analogue GUB014295. Secondary objectives are to characterize the pharmacokinetics (PK) of the long-acting amylin-analogue GUB014295 and to investigate if the long-acting amylin-analogue GUB014295 has possible pharmacodynamic effects measured as weight changes and changes in gastric emptying (paracetamol concentration) and changes in glucose, insulin, C-peptide, and glucagon during a mixed meal test.

Conditions: Healthy Volunteers, Overweight
Being tested: GUB014295, GUB014295-PLACEBO
Keywords: Weight management
Medical subject headings: Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GUB014295Drug
Also called GUBamy
GUB014295 is a long-acting amylin analogue in development, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study
GUB014295-PLACEBODrug
GUB014295-PLACEBO is matching GUB014295 in appearance, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study

Study groups in NCT06144684
Study group	Role	What they receive
Placebo	Placebo comparator	placebo solution Receives: Drug: GUB014295-PLACEBO
GUB014295	Active comparator	GUB014295 solution 5 mg/mL Receives: Drug: GUB014295

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety - Adverse Events (AE) incidence
To provide safety information for GUB014295 by assessing: incidence of AEs categorized in System Organ Class (SOC) according to MedDRA (and evaluating severity and duration for SOC). No formal hypothesis will be tested in the study. Descriptive summaries for all safety safety data for all placebo, each active treatment and all active will be provided (including changes from baseline)
Measured: 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
Safety - changes in vital signs
To provide safety information for GUB014295 by assessing: Any changes from baseline for vital signs including: Blood pressure, Pulse/heart rate, oral temperature and respiratory frequency summarized as a ratio (baseline/end of trial).
No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to end of trial) for all safety safety data for all placebo, each active treatment and all active will be provided.
Measured: 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
Safety - Safety laboratory parameters
To provide safety information for GUB014295 by assessing a wide range of laboratory parameters within hematology, coagulation, clinical chemistry, virology, urinalysis.
No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to day end of trial)) for all safety safety data for all placebo, each active treatment and all active will be provided.
Measured: 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

Secondary outcomes (5)

Pharmacokinetic (PK) - Tmax and Cmax
PK parameters: Tmax, (time of observed maximum concentration), Cmax (maximum observed concentration), for GUB014295.
Measured: from dosing (day 0) until maximum concentration after final dose
Pharmacokinetic (PK) - area under the concentration curve (AUC)
PK parameters:
AUC(0-72) area under the curve for the GUB014295 measured from dosing, until 72 hours post dose, AUC(0-168) area under the curve for the GUB014295 measured from dosing, until 168 hours post dose, AUC(0-last) area under the curve for the GUB014295 measured from dosing, until the time of last measurable concentration, AUC(0-inf) area under the curve for the GUB014295 concentration from dosing, extrapolated until infinity.
Measured: 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
Pharmacokinetic (PK) - T1/2
PK parameters: T1/2: Terminal elimination half-life,
Measured: 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
Pharmacokinetic (PK) - CL/F
PK parameters:
CL/F: Total body clearance (CL) calculated after single subcutaneous administration where F (fraction of bioavailability) is unknown,
Measured: 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
Pharmacokinetic (PK) - Vz/F
PK parameters:
Vz/F: apparent volume of distribution (Vz) based on terminal phase calculated using AUC(0-inf) after a single subcutaneous administration where F (fraction of bioavailability) is unknown,
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 20235 Jan 2026

First posted22 Nov 2023
Study start29 Nov 2023
Primary completion5 Jan 2026
Study completion5 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: This phase 1 study, will be conducted to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending subcutaneous doses of GUB014295
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06144684
Sponsor's protocol ID: GUC17-01
Other IDs: 1008236
Status last verified: Jan 2026
First submitted: 8 Nov 2023
Last updated: 15 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06144684
Acronym / sponsor ID: GUC17-01
Conditions: Healthy Volunteers, Overweight
Keywords: Weight management
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Collaborators: Quotient Sciences
Study start: 29 Nov 2023 (actual)
Primary completion: 5 Jan 2026 (actual)
Study completion: 5 Jan 2026 (actual)
First posted: 22 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a phase 1 clinical trial of a new long-acting amylin analogue GUB014295 in two parts.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: This phase 1 study, will be conducted to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending subcutaneous doses of GUB014295

Arm	Type	Receives
Placebo	Placebo comparator	Drug: GUB014295-PLACEBOplacebo solution
GUB014295	Active comparator	Drug: GUB014295GUB014295 solution 5 mg/mL

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (37 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GUB014295Also: GUBamyGUB014295 is a long-acting amylin analogue in development, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study	Drug	GUB014295
GUB014295-PLACEBOGUB014295-PLACEBO is matching GUB014295 in appearance, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study	Drug	Placebo

Primary outcome

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
To provide safety information for GUB014295 by assessing: incidence of AEs categorized in System Organ Class (SOC) according to MedDRA (and evaluating severity and duration for SOC). No formal hypothesis will be tested in the study. Descriptive summaries for all safety safety data for all placebo, each active treatment and all active will be provided (including changes from baseline)
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
To provide safety information for GUB014295 by assessing: Any changes from baseline for vital signs including: Blood pressure, Pulse/heart rate, oral temperature and respiratory frequency summarized as a ratio (baseline/end of trial). No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to end of trial) for all safety safety data for all placebo, each active treatment and all active will be provided.
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
To provide safety information for GUB014295 by assessing a wide range of laboratory parameters within hematology, coagulation, clinical chemistry, virology, urinalysis. No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to day end of trial)) for all safety safety data for all placebo, each active treatment and all active will be provided.

5 secondary outcomes

Pharmacokinetic (PK) - Tmax and Cmax
Time frame: from dosing (day 0) until maximum concentration after final dose
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sharan Sidhu principal investigator

Quotient Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GUB014295 in people with Healthy Volunteers and Overweight, run by AbbVie at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06144684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.