Weight ManagementPhase 1NCT06562907
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study testing GS-4571 and Omeprazole in people with Weight Management, run by Gilead Sciences at 3 sites in United States.
Trial summary
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- GS-4571 and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Aug 2024to Feb 2027
- Phase
- Phase 1
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
- Age 18 through 55 years, for Parts A, B, and C, and 18 through 65 years, for Part D.
- Individuals must be glucagon-like peptide-1 receptor agonist (GLP-1RA) naïve OR last dose was at least 6 months prior to screening.
- Part A (SAD) and Part B (Food/PPI Effect): eligible individuals in Cohorts 1-4, (optional cohort 5) and 6 will include healthy individuals with BMI of ≥ 19 and < 30 kg/m^2, and no significant medical history.
- Individuals will also be in good general health as determined by the investigator at the screening evaluation performed no more than 28 days prior to the scheduled first dose.
- Part C (MAD in nondiabetic obese individuals): Eligible individuals in Cohorts 7-9 and (optional cohort 10) will be individuals with obesity with BMI ≥ 30 kg/m^2 and < 45 kg/m^2 with a total body weight > 50 kg, and nondiabetic (HbA1c < 6.5%). Eligible individuals will also be individuals with stable body weight (< 5% change) for 90 days prior to screening visit based on individual report.
- Part D (multiple doses in non-obese T2DM): eligible individuals in Cohort 11 will be individuals with T2DM HbA1c ≥ 7.0% and ≤ 10.5% with BMI of ≥ 19 and < 30 kg/m^2 and treated with diet and/or exercise, and/or metformin monotherapy.
Who cannot join
- Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with individual treatment, assessment, or compliance with the protocol. This would include acute pancreatitis, or history of pancreatitis, acute gallbladder disease, and renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes [with the exception of T2DM for individuals included in Part D only]), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
- Current symptoms of diabetic retinopathy or examination indicating diabetic retinopathy within one year of screening.
- Any electrolyte disturbances identified at screening considered to be clinically significant in the opinion of the investigator (eg, hypokalemia, hypocalcemia, or hypomagnesemia).
- Any condition that could lead to electrolyte disturbances (eg, eating disorder) in the opinion of the investigator.
- History of syncope, palpitations, or unexplained dizziness.
- Active, or history of, significant cardiac disease or conduction abnormality
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- History of implanted defibrillator or pacemaker.
- Have been treated with the following within 6 months prior to screening or is expected to receive these agents during the study: GLP-1RAs, systemic steroids, immunosuppressant therapies, or chemotherapeutic agents (eg, corticosteroids, immunoglobulins, other immune or cytokine-based therapies).
- Previously stopped use of GLP-1RAs secondary to severe side effects including nausea, constipation, diarrhea, or emesis.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
United States3 sites, 3 recruiting
- Recruiting
Qps-Mra, Llc.
Miami, Florida, 33143
- Recruiting
ICON
Salt Lake City, Utah, 84124
- Recruiting
ICON Early Phase Services, LLC
San Antonio, Texas, 78232
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Oral Doses of GS-4571 in Healthy Participants, Multiple Ascending Oral Doses of GS-4571 in Nondiabetic Obese Participants and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM), and to Evaluate the Effect of Food and an Acid-Reducing Agent on Pharmacokinetics of GS-4571
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM).
The primary objectives of this study are:
- To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571.
- To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571.
- To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.
- Conditions
- Weight Management
- Being tested
- GS-4571, Placebo, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-4571Drug
Administered orally
PlaceboDrug
Administered orally
OmeprazoleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A Single-ascending Dose (SAD) in Healthy Participants | Experimental | Participants will be randomized into 4 + (optional) 1 dose escalating cohorts and will receive GS-4571 or placebo to match (PTM) GS-4571 on Day 1, to determine the maximum tolerated dose:
* Cohort 1: Dose 1 GS-4571, administered orally as a single dose, in a fasting state.
* Cohort 2: Dose 2 GS-4571, administered orally as a single dose, in a fasting state.
* Cohort 3: Dose 3 GS-4571, administered orally as a single dose, in a fasting state.
* Cohort 4: Dose 4 GS-4571, administered orally as a single dose, in a fasting state.
* Cohort 5 (optional): Dose 5 GS-4571, administered orally as a single dose, in a fasting state. Receives: Drug: GS-4571; Drug: Placebo |
| Part B Food/PPI Effect in Healthy Participants | Experimental | Participants will be randomized into 2 sequence groups in Cohort 6 and will receive the highest dose found to be safe and well tolerated in Part A of GS-4571 and omeprazole. The two sequential groups will receive the following treatments:
* Treatment A: Up to the highest single dose of GS-4571 evaluated in Part A, fasting.
* Treatment B: Up to the highest single dose of GS-4571 evaluated in Part A, nonfasting (high-fat/high-calorie meal).
* Treatment C (optional): Omeprazole, once-daily (QD) for 5 days, fasting.
* Treatment D (optional): Omeprazole followed by up to the highest single dose of GS-4571 evaluated in Part A, 2 hours later, fasting. Receives: Drug: GS-4571; Drug: Omeprazole |
| Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese Participants | Experimental | Participants randomized in Cohorts 7-9 will be randomized to receive up to 4 escalating doses of GS-4571 or PTM QD for 12 weeks, as follows:
* Cohort 7: Up to dose determined from Part A of GS-4571 or PTM in obese participants, QD, in a non-fasting state
* Cohort 8: Up to 3-fold the Cohort 7 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state
* Cohort 9: Up to 2-fold the Cohort 8 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state
* Cohort 10 is optional and will receive GS-4571 or PTM QD for 12 weeks in case it is opened for enrollment as follows:
* Up to 2-fold the Cohort 9 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state. Receives: Drug: GS-4571; Drug: Placebo |
| Part D Multiple Dose in Nonobese Participants With T2DM | Experimental | Participants randomized in Cohort 11 will receive up to the highest dose of GS-4571 or PTM in T2DM, QD, in a non-fasting state for 12 weeks. Receives: Drug: GS-4571; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-Dose PK Parameter AUCinf of GS-4571
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time.
Measured: Up to 96 hours postdose
Single-Dose PK Parameter Cmax of GS-4571
Cmax is defined as the maximum observed concentration of drug in plasma.
Measured: Up to 96 hours postdose
Multiple-Dose Plasma PK Parameter: AUCtau of GS-4571
AUCtau is defined as area under the concentration versus time curve over the dosing interval.
Measured: Up to 96 hours postdose
Multiple-Dose Plasma PK Parameter: Cmax of GS-4571
Cmax is defined as the maximum observed concentration of drug in plasma.
Measured: Up to 96 hours postdose
Percentage of Participants of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths
Measured: Day 1 up to 95 days
Percentage of Participants of Treatment-Emergent Laboratory Abnormalities
Measured: Day 1 up to 95 days
Secondary outcomes (1)
Percentage Change From Baseline (CFB) in Body Weight in Nondiabetic Obese Participants
Measured: Day 1 up to 95 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start28 Aug 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562907
- Sponsor's protocol ID
- GS-US-506-6610
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No