Active not recruitingPhase 1

Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALV-100 in Participants With Overweight or Obesity With or Without Type 2 Diabetes

Lead sponsor

Alveus Therapeutics, Inc.

Asset

ALV-100

GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

Estimated enrollment

180

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 27-39.9•HbA1c 6.5-9%

Primary endpoint

•Safety and tolerability

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07399678

Org study IDALV-102-1

Timeline

Milestones

Study start2025-12-29actual

Study first posted2026-02-10actual

Last update posted2026-10-16actual

Primary completion2027-10estimated (month precision)

Study completion2027-10estimated (month precision)

Assets

Investigational agents

ALV-100

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

For Part A and B

•Adult male and female participants, aged 18 to 65 years, inclusive, at the time of signing the informed consent form

•Body mass index between 27.0 to 39.9 kg/m2 at Screening, both inclusive; overweight should be due to excess adipose tissue, as judged by the Investigator.

•Have a stable body weight (< 5.0 kg/11 lbs self-reported change) within 90 days prior to Screening

•Females must be surgically sterile (by means of bilateral salpingectomy, hysterectomy or bilateral oophorectomy) or be post-menopausal (defined as spontaneous cessation of menses for at least 1 year prior to Screening). Females who are post-menopausal and < 55 years must have a follicle-stimulating hormone level > 40 IU/L at Screening.

•Males with female partners of child-bearing potential must be willing to practice abstinence or must agree to use condom as contraception throughout the duration of the study. This criterion may be waived for male participants who have had a documented successful vasectomy > 6 months before signing the ICF.

For Part B only

•Diagnosis of Type 2 Diabetes for at least 180 days prior to Screening.

•Glycemic control managed by diet and exercise alone or by stable treatment with metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT-2i), with no dose changes within 3 months prior to Screening.

•Hemoglobin A1c (HbA1c) between 6.5 % and 9.0% (equivalent to 48-75 mmol/mol), both inclusive, at Screening.

Exclusion criteria

For Part A and B

•History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below or equal to 500 mg/dL (5.65 mmol/L) is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with type 2 diabetes in Part B) at the discretion of the Investigator.

•Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.

•Current or history of chronic or acute pancreatitis.

•Obesity caused by known endocrinologic disorders (e.g., Cushing syndrome) or monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).

•History of major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or anxiety disorder).

•Lifetime history of a suicide attempt or of any suicidal behavior by endorsement of (answered yes to) any of the items in the suicidal behavior section on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.

•Systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg at Screening.

•History of or current cardiovascular disease, including but not limited to stable and unstable angina, myocardial infarction, congestive heart failure, transient ischemic attack, stroke, clinically significant arrhythmias and conduction disorders or venous thromboembolism.

Part A only

• History or clinical evidence of Type 1 or Type 2 diabetes mellitus, including HbA1c ≥ 6.5% and/or a fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) at Screening (female participants with a history of gestational diabetes are allowed).

Part B only

•Fasting plasma glucose (FPG) > 270 mg/dL (15.0 mmol/L) at Screening.

•Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (within1.5 years from Screening) ophthalmologic examination.

•Severe neuropathy as judged by the investigator.

•Advanced nephropathy (defined as albuminuria ≥ 300 mg/g).

•History of severe hypoglycemia or hypoglycemic unawareness as judged by the investigator.

Endpoints (11)

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

Other (unclassified)

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Pharmacodynamic (PD) impact on body weight

Time frame:Baseline, Week 32 and Week 52

descriptive

Secondary/protocol endpoint

Pharmacodynamic (PD) impact on body weight percentage

Time frame:Baseline, Week 32 and Week 52

descriptive

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Pharmacodynamic (PD) impact of ALV-100 on glycemic parameters (Part B Only)

Time frame:Week 32 and Week 52

descriptive

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Safety and tolerability

Time frame:From First Dose to Week 52

descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - Cmax, MD

Time frame:From First Dose to Week 52

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - AUC(0-τ), MD

Time frame:From First Dose to Week 52

concentration, descriptive

Secondary/protocol endpoint

Immunogenicity

Time frame:From Baseline to Week 52

descriptive

Secondary/protocol endpoint

Relationship between ALV-100 serum concentration and QTc interval changes (Part A Only)

Time frame:From First Dose to Week 52

concentration, descriptive

Secondary/protocol endpoint

Hypoglycemic Safety (Part B Only)

Time frame:From Baseline to Week 52

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Paracetamol (acetaminophen) absorption test (PAT) (Part A Only)

Time frame:From First Dose to Week 52

descriptive

Secondary/protocol endpoint/low confidence

Pharmacodynamic (PD) impact of ALV-100 on antidiabetic medication (Part B Only)

Time frame:From Baseline to Week 32

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.