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

NCT07399678 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ALV-102-1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes

Conditions

Overweight or Obese Adults; Overweight or Obese, Type 2 Diabetes

Keywords

Overweight, Obese, Obesity, Type 2 Diabetes, Weight loss

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Incidence of treatment emergent adverse events (TEAEs)

  From First Dose to Week 52

Secondary Outcomes (10)

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

  From First Dose to Week 52

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

  From First Dose to Week 52

• Pharmacodynamic (PD) impact on body weight

  Baseline, Week 32 and Week 52

• Pharmacodynamic (PD) impact on body weight percentage

  Baseline, Week 32 and Week 52

• Immunogenicity

  From Baseline to Week 52

Study Arms (10)

Part A - Cohort 1 (ALV-100)

EXPERIMENTAL

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Drug: ALV-100

Part A - Cohort 1 (Placebo)

PLACEBO COMPARATOR

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Drug: Placebo

Part A - Cohort 2 (ALV-100)

EXPERIMENTAL

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Drug: ALV-100

Part A - Cohort 2 (Placebo)

PLACEBO COMPARATOR

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Drug: Placebo

Part A - Cohort 3 (ALV-100)

EXPERIMENTAL

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Drug: ALV-100

Part A - Cohort 3 (Placebo)

PLACEBO COMPARATOR

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Drug: Placebo

Part A - Cohort 4 (ALV-100)

EXPERIMENTAL

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Drug: ALV-100

Part A - Cohort 4 (Placebo)

PLACEBO COMPARATOR

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Drug: Placebo

Part B - T2D Cohort (ALV-100)

EXPERIMENTAL

Participants with overweight or obesity with type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Drug: ALV-100

Part B - T2D Cohort (Placebo)

PLACEBO COMPARATOR

Participants with overweight or obesity with type 2 diabetes will receive placebo by subcutaneous injection.

Drug: Placebo

Interventions

ALV-100 DRUG

Participants will receive multiple ascending doses of ALV-100.

Part A - Cohort 1 (ALV-100); Part A - Cohort 2 (ALV-100); Part A - Cohort 3 (ALV-100); Part A - Cohort 4 (ALV-100); Part B - T2D Cohort (ALV-100)

Placebo DRUG

Participants will receive placebo matching ALV-100, volume-matched to active dose.

Part A - Cohort 1 (Placebo); Part A - Cohort 2 (Placebo); Part A - Cohort 3 (Placebo); Part A - Cohort 4 (Placebo); Part B - T2D Cohort (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 7.0 % and 9.0% (equivalent to 53-75 mmol/mol), both inclusive, at Screening.

You may not qualify if:

• For Part A and B
• History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however mild dyslipidemia, defined as screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below 300 mg/dL (3.39 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.

Sponsors & Collaborators

• Alveus Therapeutics, Inc.: lead

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Karen Tornøe, MD, PhD

  Alveus Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

+1 215-607-2243; clinicaltrials@alveustx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In Part A, four treatment cohorts of participants with overweight or obesity will be administered varying dose escalation regimens of ALV-100. Each cohort will explore the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ALV-100. Each cohort will be comprised of 40 participants with 32 participants receiving active treatment and 8 participants receiving placebo in a 4:1 ratio. In Part B, a single cohort of participants with overweight or obesity, and T2D will be enrolled. This cohort will explore the safety (including glycemic safety), tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ALV-100. Fifteen (15) participants will receive active treatment, and 5 participants will receive placebo.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 10, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)